JOIN OUR TEAM
BioGX is a growing company. We are always on the lookout for talented scientists and technicians with an entrepreneurial spirit, a dedication to excellence, and experience with molecular detection methods and general molecular biology. We offer a competitive salary and benefits package. Please check our currently available positions below.
Accounts Payable Specialist
Accounts Payable Specialist at BioGX in Birmingham, AL
The Accounts Payable Specialist is responsible for general reconciliation and front-line support duties. The position requires an enthusiastic team player with excellent attention to detail, and communication skills. Previous accounts payable experience is required, and Quickbooks experience is a plus. A/P Specialist must keep all financial and customer-related matters confidential.
Essential Duties and Responsibilities (other duties may be assigned):
- Works under direct supervision of the Finance Manager.
- Assist with preparations for Accounts Payable check run, and occasional Purchase Order generation.
- Manage Accounts Payable inbox, accept and process invoices, general communication with vendors. Obtain and organize the W-9 file.
- Assist with receipt management, expense reimbursement and reconciliation.
- Review and enter vendor invoices into Quickbooks.
- Review and organize packing slips to be matched with vendor invoices.
- Work with Finance and Sales & Marketing to check credit references on new customers and establish appropriate payment arrangements.
- Report financial and purchasing information to executive management, and discuss, as requested.
- Perform general office work such as filing, answering main phone, and receiving/sorting mail.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Strong attention to detail
- Excellent oral and written communication skills
- Strong organizational skills
- Ability to manage deadlines, prioritize and adjust to meet goals
- Excellent problem identification and solving skills
- In-depth knowledge and experience in bookkeeping/accounting
- Ability to handle and resolve conflicts and work under stressful conditions
- Fluent in the use of Microsoft Word, Excel, PowerPoint, Google Suite (Docs, Sheets, Slides), QuickBooks and Zoho.
Education and Experience: A Bachelor’s Degree preferred or equivalent relevant A/P experience with at least 3-5 years of related field experience.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Good problem solving, judgment and decision-making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $18.00 – $20.00 per hour
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Clinical Affairs Manager
Clinical Affairs Manager at BioGX – Birmingham, AL
***Please include a cover letter explaining why you are the best candidate for this position.***
Purpose of the Position:
Provides leadership, direction and support for the implementation and sustainable initiatives to document clinical evidence for select BioGX products. Serves as the subject matter expert who manages clinical performance, scientific validity, and analytical performance activities for the organization. Ensures effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
The Clinical Affairs Manager will play a direct role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
Essential Duties and Responsibilities:
- Directly oversees domestic & international clinical evidence activities prescribed by applicable regulatory agencies
- Provide guidance and expertise to functional areas where needed in order to continually meet evolving regulatory requirements
- Develop and maintain protocols needed to conduct scientific validations and to generate relevant clinical evidence for regulatory submissions
- Prepare written final reports containing interpretations and conclusions that are supported by results from data analysis
- Develop continuing education training materials and deliver effective training on protocols for conducting clinical studies
- Collaborate with Research & Development and Regulatory Affairs when preparing for clinical studies
- Participate in company audits and implement measurable actions necessary to achieve planned results following audits
- Adheres to good manufacturing practices and good documentation practices
- Domestic and international travel to off-site laboratories and clinical sites required
- Exercises independent judgement and decision making
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
- Ability to plan and manage complex and successful projects
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Five or more years’ experience in a US FDA-regulated manufacturing environment having clinical trials expertise
- Experience working within the framework of ISO 13485 international standards, FDA 21CFR820, In-Vitro Diagnostic Directive (IVDD), In-Vitro Diagnostic Regulation (IVDR), and quality management systems
- Experience with analyzing technical data in the area of molecular diagnostics
- Excellent written and verbal communication skills
- Must have outstanding presentation and public speaking skills
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word/Good Docs), spreadsheet (MS Excel/Google Sheets), graphical, and file management software
- Proficient in typing and keyboard topology
- Extremely detail-oriented with strong planning and organizational skills
- Self driven
- Able to work without supervision
Education and Experience:
- Bachelor’s Degree required; Master’s Degree or PhD preferred
Experience:
- ISO 13485 international standards: 3 years (Preferred)
- In-Vitro Diagnostic Directive (IVDD): 3 years (Preferred)
- QMS: 3 years (Preferred)
- FDA 21CFR820: 3 years (Preferred)
- US FDA-regulated manufacturing environment: 5 years (Preferred)
- In-Vitro Diagnostic Regulation (IVDR): 3 years (Preferred)
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Excellent problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while sitting or standing. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.
Job Type: Full-time
Salary: $60,000.00 – $80,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Inside Sales Specialist (Part-time), Dallas
Inside Sales Specialist (Part-time) at BioGX in Dallas, TX
Purpose of the Position:
You will uncover new sales opportunities through internet-based research, review of business directories, follow up of client referrals, and exploration of lead lists. The ultimate purpose of the position is to create incremental revenue opportunities and, where possible, convert to actual revenue.
Essential Duties and Responsibilities (other duties may be assigned):
- Identify revenue generating business opportunities using various research based methods (internet, referrals, lead lists, cold calling, triangulation, etc.)
- Source new sales opportunities through inbound lead follow-up and outbound cold calls and emails
- Understand customer needs and requirements
- Route qualified opportunities to the appropriate internal resources for further development and closure
- Close sales, where applicable, and achieve quarterly quotas
- Research accounts, identify key players and generate interest
- Maintain and expand ZoHo database of prospects
- Team with business partners to build pipeline and close deals
- Forecast sales
- Develop sales strategies to effectively generate new business opportunities and leads
- Evaluate customers needs and build productive long lasting relationships
- Meet personal and team sales targets
- Research accounts and generate or follow through sales leads
- Attend meeting, sales events and trainings to keep abreast of the latest developments
- Report and provide feedback to management using financial statistical data
- Performs duties and responsibilities as assigned by Manager
- Present, promote and sell products/services using solid arguments to existing and prospective customers
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Establish, develop and maintain positive business and customer relationships
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Achieve agreed upon sales targets and outcomes within schedule
- Coordinate sales effort with team members and other departments
- Analyze the territory/market’s potential, track sales and status reports
- Supply management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Continuously improve through feedback
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven inside sales experience
- Track record of over-achieving quota
- Strong phone presence and experience dialing dozens of calls per day
- Proficient with corporate productivity and web presentation tools
- Experience working with ZoHo, Salesforce.com or similar CRM
- Excellent verbal and written communications skills
- Strong listening and presentation skills
- Ability to multi-task, prioritize, and manage time effectively
- Familiarity with different sales techniques and pipeline management
- Computer use competency
- Strong communication, negotiation and interpersonal skills
- Self motivated and driven
- BA/BS degree or equivalent, preferably in Life Sciences
- Ability to handle and resolve conflicts and work under stressful conditions.
- Sound organizational and coordination skills.
- Proven job reliability, diligence, dedication and attention to detail.
- Fluent in the use of Microsoft Word, Excel, PowerPoint, CRM databases, and the Google Suite (Docs, Sheets, Slides).
Education and Experience: The ideal candidate will have a Bachelor’s Degree in Life Sciences. 2+ years of sales experience in healthcare industry preferred.
Language Skills: Must be proficient in writing and communicating in the English language. Multi-lingual a definite plus.
Mathematical Skills: Must be consistent with level of education.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Part-time
Pay: $20.00 per hour
Director of Sales, Dallas, TX
Director of Sales at BioGX in Dallas, TX
***REQUIRED – Please include a cover letter explaining why you are the best candidate for this position along with salary requirements.***
Purpose of the Position:
Responsible for executive leadership relative to planning and implementing sales, sales & customer support, and business partnership programs ensuring that the voices of customers and partners are heard, resulting in satisfied customers and achieving profitable revenue targets. Includes both short and long-range objectives for existing and new markets by performing the following duties personally or through subordinates.
Essential Duties and Responsibilities (other duties may be assigned):
- Reports to the Senior Vice President, Global Operations.
- Participates in key customer meetings and senior level business meetings.
- Develops and implements strategic sales plans and sales forecasts to achieve corporate objectives for products and services to achieve strategic corporate revenue and market expansion.
- Develops and manages sales, and sales & customer support operating budgets.
- Achieves satisfactory profit/loss ratio and market share in relation to industry and economic trends.
- Oversees and evaluates sales research and customer feedback. Makes recommendations to improve and adjusts to the sales strategy to meet changing customers, market, sales and competitive conditions.
- Routinely monitors competitor products, sales and marketing activities.
- Actively establishes and maintains Key Opinion Leaders (KOL) relationships and connects with industry advocates, industry influencers and key strategic partners.
- Directs sales forecasting activities and sets performance goals accordingly.
- Directs staffing, training, and performance evaluations to develop sales & customer support and sales teams to expand partner and direct sales.
- Directs sales channel development activity and coordinates sales distribution by establishing sales territories, quotas, and goals.
- Represents the Company at key trade association meetings to promote services and product.
- Meets with key partners and clients to assist sales representative with maintaining relationships and negotiating and closing deals.
- Coordinates liaison between sales departments and other sales related partners and channels.
- Analyzes and controls expenditures of division to conform to budgetary requirements.
- Prepares periodic sales reports showing sales volume, potential sales, and areas of proposed client base expansion.
- Reviews and analyzes sales performances against programs, quotas and plans to determine effectiveness.
- Directs and clarifies customer requirements and input to research and development team.
- Acts as customer’s voice for internal teams.
- Represents BioGX at trade shows, conferences and distributor partner meetings.
- At times, may require greater than 50% overnight travel.
- Work with Director, Marketing & Product Support and Innovation to ensure achievement of the strategic goals and objectives of the business products.
Supervisory Responsibilities: Supervises Sales & Customer Support Team members
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience of nucleic acid, PCR-based diagnostic test product development experience.
- Well organized and efficient with handling multiple tasks at the same time.
- Technical supervisory experience.
- Deep Market Knowledge of Diagnostic Industry including Cancer, infectious diseases and genetics.
- Experienced and competent in assay and platform development processes.
- Sales and executive management experience. Senior marketing experience is a plus.
- Connected with industry thought leaders for rapid market development.
- Proficient Communicator skills with superior ability to present to customers, executive team and BioGX team members.
- Customer/Client/Partner Focus.
- Demonstrated Leader and coach.
- Exceptional problem solving and analytical skills.
- Proven as results driven.
- Strategic Thinkers
- Fluent in the use of Microsoft Word, Excel, PowerPoint and Google Suite.
- Excellent written and verbal communication skills.
- Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
- Ability to effectively function, manage and resolve conflicts under stressful conditions.
Education and Experience: The ideal candidate will have a Bachelor’s degree in Chemistry, Molecular Biology, Medical Technology or related field with 10 years of experience in sales, business development and strategic partnerships with progressive management experience.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Manager of Operations
Manager of Operations at BioGX in Birmingham, AL
Purpose of the Position:
Responsible for planning, implementation and compliance of Research Use Only and IVD manufacturing systems using good manufacturing practices (GMP) and adherence to quality management system (QMS) requirements. Develop plans, in partnership with key collaborating functional areas within and outside of department, to provide appropriate manufacturing facility and controls to achieve the company’s milestone objectives. The plans include materials acquisition, workflow monitoring, supplier contracts, validation, goal setting, production scheduling, warehousing, shipping and staff development to meet requirements of existing and new products. This person is directly responsible for leadership of the Manufacturing packaging and QC units to develop project plans, projecting and recommending staffing requirements to achieve timelines and maintaining expense controls.
Essential Duties and Responsibilities (other duties may be assigned):
- Accomplishes manufacturing packaging and QC staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures
- Manages, coordinates and executes reagent manufacturing packaging and Quality Control procedures
- Assist with the compiling and submittal of manufacturing QC data and batch records for QA review and approval
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
- Manage manufacturing packaging and QC personnel and testing schedule
- Manage development of reagent manufacturing QC processes and documentation
- Manage, plan and coordinate resources for product stability testing
- Complies with ISO 13485 and cGMP standards.
- Support continuous quality improvement
- Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities.
- Completes timely product QC and packaging by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; resolving QC testing issues promptly.
- Maintains high quality by establishing and enforcing organization standards.
- Ensures operation of equipment by identifying problems, calling for repairs; evaluating new equipment and techniques.
- Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
- Resolves personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.
- Contributes to team effort by accomplishing related results as needed.
- Understand, train personnel, and enforce strict adherence to the applicable SOPs of the Quality System, as well as the Manufacturing Guidelines
- Assist in attaining quarterly and annual production goals
- Learn and enforce company safety policies and practices
- Lead or support Lean Manufacturing initiatives that involve across-functional team (outside of Operations)
- Uses chemistry, biochemistry, and molecular biology knowledge to assist in solving the range of problems associated with molecular tests on diverse platforms.
- Responsible for carrying out work to company standards, including documentation, accurate record keeping, and maintaining related work schedules in order to support product development timelines.
- Performs data analysis.
- Present results at meetings as required and proposes new strategies and methods to address immediate and upcoming technical issues.
- Compiles and submits manufacturing batch records for manufacturing’s review and QC testing.
- Assists in process scale-up to transition from pilot lots to full production-scale manufacturing.
- Assists in forecasting enzyme, oligo primer and probes.
- Performs job functions in compliance with QMS standards.
- Performs additional tasks as assigned.
Supervisory Responsibilities:
- Responsible for the coordination and supervision of Manufacturing QC staff.
- Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and coordinate training of employees; planning, assigning, and supervising work; rewarding and disciplining employees; addressing complaints and resolving personnel conflicts and issues.
Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience translating development product designs into manufactured products
- Project planning
- Supervisory experience
- Budgetary planning and management experience
- Specialized knowledge and experience in molecular diagnostics and real-time PCR is required.
- Performance management experience
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in IVD business.
- Working knowledge of cGMP and Quality Assurance systems used in IVD products.
- Practical experience with clinical investigations during research, development, and validation stages, the latter in support of impending regulatory submissions (510k, PMA, etc.).
- Demonstrated familiarity with relevant publications, patents and processes leading to such.
- Understanding of bioinformatics, including nucleic sequence alignments, GenBank searches, oligo primer and probe design for use with Taqman, Scorpions, and other chemistries.
- Firsthand experience with medical devices manufacture (and/or biotechnology pharmaceuticals with knowledge of IVD requirements)
- Possess the skills necessary to create and lead a culture of commitment to the values vital to organizational development and growth
- Proven ability to deliver productivity to plan
- Willing to resolve problems
- Ability to collaborate and work effectively with diverse groups, incorporate the input of others to improve our processes, and align with internal customers
- Committed to developing and empowering others; to accomplish goals through the skills of persuasion, influence and negotiation
- Must have excellent communication skills (listening, written, verbal, presentation)
- Ability to interface and exchange information with all levels within the company’s workforce
- A team player that works with management and technicians to strive for continuous improvement
- Knowledge of bills of materials and other planning activities
Education and Experience: B.S. science or engineering or related discipline with at least 2 years leadership experience in an FDA/ISO regulated manufacturing environment.
Language Skills: Must be proficient in writing and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision-making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Manager, Product Delivery
Manager, Product Delivery at BioGX – Birmingham, AL
Job Description
Purpose of the Position: Management of Product Delivery staff by organizing and monitoring the areas of Design Transfer, Production, and Quality Control (QC). This involves coordinating with R&D scientists for all steps requiring the testing and transfer of new products to Manufacturing, overseeing production and test/validation builds and QC work-flow, maintaining quality systems compliance, planning, schedules, resources, and product QC testing for release and shipping. Assist Research and Development (R&D) scientists in performing laboratory research as required to finalize development and product transfer to manufacturing of multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select appropriate control materials, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements. Includes design, preparation, dilution, aliquoting, and maintenance of DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
Essential Duties and Responsibilities (other duties may be assigned):
- Manage production build, product transfer and QC staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, training, counseling, motivating, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
- Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
- Work with the R&D staff to transfer developed products, managing the scale-up to transition from pilot lots to full production-scale manufacturing.
- Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of development and product transfer problems associated with genetic tests for the presence of specific DNA and RNA sequences as required.
- Carries out feasibility and development experiments, protocols, procedures, and report writing supporting product transfer for timely completion of project(s).
- Maintain current knowledge of competitive technologies, new principles and theories relevant to product R&D, product transfer, and commercialization in an ISO 13485 mfg. environment.
- Designs, prepares, dilutes, aliquots, and maintains DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
- Document product transfer protocols, results of studies and process design/development history to meet QMS requirements.
- Works with BioGX Marketing dept. to prioritize product releases.
- Resolves personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.
- Assist in attaining quarterly and annual production goals.
- Learn and enforce company safety policies and practices.
- Manages, coordinates and executes reagent manufacturing build, product transfer and Quality Control procedures and schedules.
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures.
- Manage, plan and conduct product stability testing.
- Complies with ISO 13485 and cGMP standards.
- Support continuous quality improvement.
- Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities.
- Completes timely product delivery by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; resolving Product Delivery issues promptly.
- Maintains high quality by establishing and enforcing organization standards.
- Ensures operation of equipment by identifying problems, calling for repairs; evaluating new equipment and techniques.
- Serves as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned.
Supervisory Responsibilities: May supervise one or more depending upon project scope.
- Responsible for the coordination and supervision of Product Delivery staff.
- Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and coordinate training of employees; planning, assigning, and supervising work; rewarding and disciplining employees; addressing complaints and resolving personnel conflicts and problems.
- Assist in attaining quarterly and annual production goals
- Learn and enforce company safety policies and practices.
- Lead and/or support Lean Manufacturing initiatives.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience of nucleic acid, PCR-based diagnostic test product development experience.
- Experienced with DNA and RNA sample processing and sample stabilization procedures, and with BSL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures.
- Familiar with the use of Arrhenius and stability relationships to establish product stability claims.
- Direct experience with ISO design control procedures and participation in development, verification, validation stages of technology transfer into a GMP manufacturing unit.
- Well organized and efficient with handling multiple tasks at the same time.
- Technician supervisory experience.
- Experienced with short, intermediate and longer term project planning and clinical research.
- Fluent in the use of Microsoft Word, Excel, PowerPoint.
- Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
- Ability to handle and resolve conflicts and work under stressful conditions.
- First hand experience with medical devices manufacture (and/or biotechnology pharmaceuticals with knowledge of IVD requirements)
- Possess the skills necessary to create and lead a culture of commitment to the values vital to organizational development and growth
- Proven ability to deliver productivity to plan
- Willing to resolve problems
- Ability to collaborate and work effectively with diverse groups, incorporate the input of others to improve our processes, and align with internal customers
- Committed to developing and empowering others; to accomplish goals through the skills of persuasion, influence and negotiation
- Must have excellent communication skills (listening, written, verbal, presentation)
- Ability to interface and exchange information with all levels within the company’s workforce
- A team player that works with management and technicians to strive for continuous improvement
- Knowledge of bills of materials and other planning activities
Education and Experience: The ideal candidate will have a Ph.D. or equivalent degree in Chemistry, Molecular Biology or related field. Additional field experience (5 to 10 years) is important to succeed in the job function.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments.
While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate. Assist Research and Development scientists in performing laboratory research as required to finalize development and product transfer to manufacturing of multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select appropriate control materials, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements. Includes design, preparation, dilution, aliquoting, and maintenance of DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
Job Type: Full-time
Salary: $60,000.00 – $70,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Manufacturing Technician
Manufacturing Tech at BioGX – Birmingham, AL
Purpose of the Position:
The Manufacturing Technician is responsible for general laboratory duties focused on manual and automated filling and packaging of standards, controls and panels for commercially available nucleic acid tests and other advanced reagents. The Manufacturing Technician is expected to follow standard operating procedures and quality systems documentation in a GMP environment.
Essential Duties and Responsibilities (other duties may be assigned):
- Coordinates and executes reagent fill and pack procedures
- Updates manufacturing batch records for manufacturing’s review
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
- Assists in process scale-up to transition from pilot lots to full production-scale reagents filling and packaging
- Assists in inventory management
- Assists in maintaining production and laboratory equipment
- Dispense and aliquot chemicals and reagents from bulk containers
- Print and apply container labels
- Performs job functions in compliance with QMS standards.
- Supports continuous quality improvement
Supervisory Responsibilities: N/A
Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven ability to deliver productivity to plan
- Must have excellent communication skills (listening, written, verbal, presentation)
- Proven math skills
- Experience with Excel
- Demonstrated attention to detail
- Proven ability to meet deadlines and work under aggressive timelines
- Demonstrated ability to work effectively in a team environment
- Accurate and precise manual pipetting and measuring techniques
- Experience working with automated dispensing equipment is preferred, but not required
Education and Experience: High School degree or equivalent required. At least 2 years of hands-on experience in a GMP manufacturing environment.
Language Skills: Must be proficient in writing, and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time, Part-time
Pay: $12.00 – $14.50 per hour
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Molecular Applications Specialist, Dallas
Molecular Applications Specialist at BioGX in Dallas, Texas
Purpose of the Position:
Responsible for on-site customer collaboration, training, education and troubleshooting. Must have the ability to support customers in all aspects of product creation, development, and implementation. Works independently and closely with Sales & Marketing coordinating customer implementation and actualization of our technology service. Responsible for a defined set of customers within territory and should have the ability to be flexible, think creatively and make customer satisfaction a priority.
Essential Duties and Responsibilities (other duties may be assigned):
● Independently schedules and conducts collaboration, training, and field support activities at customer sites
● Performs technical and application support including troubleshooting via telephone, fax and computer (e-mail and Internet), and in person.
● Develops and maintains strong customer relationships by acting as a liaison between the customer and various departments at BioGx.
● Reports field issues, gathers information for complaint records and internal troubleshooting, defines and develops comprehensive solutions and provides necessary follow up to ensure customer satisfaction and technical issues are resolved.
● Contacts customers via email, telephone or in person.
● Provides follow up to customer calls as required and maintains clear and complete records of all customer interactions.
● Documents activities within the Zoho CRM system and classifies calls according to SOPs.
● Escalates issues to management as needed.
● Works closely with sales team in sales process to provide technical support
● Perform joint sales calls with sales team for customer planning, collaboration, and on-site Site Assessments as needed.
● Builds productive internal and external working relationships.
● Maintains proficiency in all BioGX molecular products.
● Maintains clinical knowledge of BioGX products.
● Monitors the competition and reports important activities (technical developments, trends within key accounts, seminars, training sessions, etc.).
● Represents BioGX at conferences, trade shows, workshops and seminars locally, regionally or nationally, as necessary.
● Assists with customer engagement programs at BioGX facilities, new hire training and other territory support as needed.
● Provides leadership and represents the voice of the customer (VOC) in cross functional teams in terms of development priorities, schedules and customer deliverables.
● Contributes to application notes, technical articles, technical and market training materials.
● Maintains administrative standards, is fiscally responsible, submits expense
reports within guidelines, and provides and maintains clear and complete records to comply with all elements of the Quality Management System relevant to the position.
● Provides backup to departmental coworkers.
● Performs other related duties as assigned by management.
● Requires greater than 50% travel.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
● Ability to work independently and shows initiative when dealing with internal and external customers and projects.
● Ability to exercise discretion, foresight and independent judgment in performing duties.
● Knowledge and experience with BSL-2 procedures and understanding of procedures necessary for processing clinical specimens.
● Technical competency with the ability to stay current in technical knowledge to troubleshoot technical questions from customers and provide information back to the customer in a helpful, courteous, positive and professional manner.
● Strong verbal and written communication and organizational skills.
● Strong and effective teaching and presentation skills.
● Computer experience, including PC network, Windows, Word, Excel, Internet and others.
● Ability and willingness to travel up to 50%+ of the time.
● Ability to organize, present, and convey complex problems or issues within and across other functions.
● Ability to multi-task and make independent decisions while working in a fast-paced environment with multiple and changing priorities.
● Ability to work in a team environment and adapt to changing plans and circumstances.
● Strong attention to details and ability to bring customer situations to satisfactory completion in a timely manner.
● Valid Driver’s License. Valid passport as applicable.
● Experience setting up reagents/kits to the clinical or research market segments.
● Experience with automation.
● Experience working in a molecular diagnostics / clinical laboratory setting.
● Resource awareness – where to go to find answers.
● Familiarity with current clinical laboratory practices and guidelines.
Education and Experience: The ideal candidate will have a Bachelor’s degree in Chemistry, Molecular Biology, Life Sciences or related field with 10 years of laboratory and field experience or M.S. degree with 5+ years of laboratory and field experience.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision-making skills are required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Location: Dallas
Salary: $50,000.00 – $65,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Molecular Sales Manager, Dallas
Molecular Sales Manager at BioGX – Dallas, Texas
Purpose of the Position: To represent our corporate services to customers and potential customers. Work with customers to create solutions and ensure a smooth sales process. Uncover new sales leads, through business directories, client referrals, tradeshow leads, cold calls, industry organizations, etc. Represent the face of our company to field based, new or existing, customers.
Essential Duties and Responsibilities (other duties may be assigned):
- Close positive revenue generating business by using various customer sales methods (cold calling, presentations etc)
- Forecast sales
- Develop sales strategies to effectively generate new business opportunities and leads
- Evaluate customers skills, needs and build productive long lasting relationships
- Meet personal and team sales targets
- Research accounts and generate or follow through sales leads
- Attend meeting, sales events and trainings to keep abreast of the latest developments
- Report and provide feedback to management using financial statistical data
- Maintain and expand client database within your assigned territory
- Performs duties and responsibilities as assigned by Manager
- Present, promote and sell products/services using solid arguments to existing and prospective customers
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Establish, develop and maintain positive business and customer relationships
- Reach potential customers through cold calling
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Achieve agreed upon sales targets and outcomes within schedule
- Coordinate sales effort with team members and other departments
- Analyze the territory/market’s potential, track sales and status reports
- Supply management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Keep abreast of best practices and promotional trends
- Continuously improve through feedback
- Travel to customer sites and tradeshows. (50%+)
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven sales experience
- Track record of over-achieving quota
- Experience working with CRM program
- Familiarity with different sales techniques and pipeline management
- Computer use competency
- Strong communication, negotiation and interpersonal skills
- Self motivated and driven
- BA/BS degree or equivalent
- Ability to handle and resolve conflicts and work under stressful conditions.
- Sound organizational and coordination skills.
- Ability and willingness to travel and work weekends.
- Proven job reliability, diligence, dedication and attention to detail.
- Fluent in the use of Microsoft Word, Excel, PowerPoint, CRM databases, and the Google Suite (Docs, Sheets, Slides).
Education and Experience: The ideal candidate will have a Bachelor’s Degree in Life Sciences. 10+ years of sales experience in healthcare industry.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $70,000.00 – $85,000.00 per year
Product Manager - Birmingham, AL or Dallas, TX
Product Manager at BioGX – Birmingham, AL
***REQUIRED – Please include a cover letter detailing why you are the best candidate for this position.***
Purpose of the Position:
To develop molecular diagnostic products by identifying product potential; conduct market research; generate product requirements; determine product specifications, production timetables, pricing, and time-integrated plans for product introduction; and develop marketing strategies.
Essential Duties and Responsibilities (other duties may be assigned):
- Determines customers’ needs and desires by specifying the research needed to obtain market information.
- Recommends the nature and scope of present and future product lines by reviewing product specifications and requirements; appraising new product ideas and/or product or packaging changes.
- Assesses market competition by comparing the company’s product to competitors’ products.
- Provides source data for product line communications by defining product marketing communication objectives.
- Obtains product market share by working with sales to develop product sales strategies.
- Assesses product market data by calling on customers with field sales people and evaluating sales call results.
- Provides information for management by preparing short-term and long-term product sales forecasts and special reports and analyses; answering questions and requests.
- Reviews inventory and product viability to assess ROI and product life.
- Brings new products to market by analyzing proposed product requirements and product development programs; preparing return-on-investment analyses; establishing time schedules with R&D and manufacturing.
- Introduces and markets new products by developing time-integrated plans with sales, advertising, and production.
- Determines product pricing by utilizing market research data; reviewing production and sales costs; anticipating volume; costing special and customized orders.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; and participating in professional societies.
- Contributes to team effort by accomplishing related results as needed.
- Performs duties and responsibilities as assigned by Manager.
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven work experience in product management.
- Proven track record of managing all aspects of a successful product throughout its lifecycle.
- Proven ability to develop product and marketing strategies and effectively communicate recommendations to executive management.
- Command of infectious disease organisms and diagnostic methodologies.
- Solid technical background with understanding and/or hands-on experience in molecular diagnostics and similar technologies.
- Strong problem solving skills and willingness to roll up one’s sleeves to get the job.
- Skilled at working effectively with cross functional teams in a matrix organization.
- Excellent written and verbal communication skills.
- MS/BS degree in Life Sciences or equivalent preferred.
- Highly skilled in product management, relationship management, people management, understanding customer needs, product development, requirements analysis, pricing, planning, competitive analysis, collaborative sales planning, understanding inventory control, financial planning and marketing strategy.
- Well organized and efficient with handling multiple tasks at the same time.
- Excellent written, interpersonal, verbal communication and presentation skills.
- Demonstrated ability to work as part of a multidisciplinary team.
- Customer management and customer facing skills and attributes.
- Experience working in process development or, a Good Manufacturing Process (GMP) controlled Operations.
- Ability to handle and resolve conflicts and work under stressful conditions.
- Sound organizational and coordination skills.
- Ability and willingness to travel and work weekends.
- Proven job reliability, diligence, dedication and attention to detail.
- Fluent in the use of Microsoft Word, Excel, PowerPoint, CRM databases, and the Google Suite (Docs, Sheets, Slides).
Education and Experience: The ideal candidate will have a Bachelor’s Degree in Marketing and/or Life Sciences. 5+ years of work experience in the healthcare industry.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: US Driver’s License required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Required travel: 25% (Required)
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Purchasing Associate
Purchasing Associate at BioGX in Birmingham, AL
Our Purchasing Associate is responsible for day-to-day management & execution of purchasing and vendor & supplier management. This position requires an enthusiastic individual with negotiation and communication skills. Extreme confidentiality in regard to all financial matters is a requirement of this position. Quality management system support and compliance to ISO 13485 standards required.
Essential Duties and Responsibilities (other duties may be assigned):
- Work under direct supervision of the Director of Operations & IT.
- Work with Research and Development, Operations teams, Executive Management, and Sales and Marketing to manage the purchase and tracking of all materials, supplies, and equipment, negotiate purchases and contracts with vendors based on product sales forecast and forecasted material requirements from Operations.
- Partner with cross-functional groups in Operations to identify process inefficiencies and/or non-value adds for improvements (e.g. cost savings, increased productivity, improved yields, quality improvement, etc.) in forecasting and purchasing of materials and supplies.
- Provide Research and Development, Operations teams, Quality Team, Executive Management, and Sales and Marketing with updates and metrics on the status of various purchasing projects as required, including metrics to monitor effectiveness
- Negotiate and continuously improve margins by lower costs of purchased goods
- Facilitate and maintain executed supplier agreements, licensure agreements, supplier self-assessments, supplier evaluations/surveys, supplier credentials & certificates (e.g. ISO and other credentials) and supplier nondisclosure agreements (NDA)
- Monitors, analyzes and regularly reports supplier performance metrics including supplier ontime delivery, supplier supplied material reject rates, and supplier’s contract requirement fulfillment performance
- Facilitates regular supplier performance update meetings with Senior Management
- Facilitates supplier selection, evaluation and re-evaluation processes as defined by procedures
- Maintains and keeps current the approved supplier list (ASL). Ensures supplier tier classifications are current with respect to supplier’s performance and changes to requirements. Updates regularly as required
- Facilitates supplier corrective action requests as required. Monitors progress through satisfactory completion
- Participate in meetings with senior level business managers as needed
- Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent verbal and written communication skills
- Strong organizational skills with ability to manage deadlines and prioritize workload and make adjustments to meet business needs.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
- Working knowledge of cGMP, international standards, and Quality Assurance systems.
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, QuickBooks and file management software.
- Proficient in typing and keyboard topology.
- Extremely detail-oriented with strong organizational skills and high quality standards.
- Ability to handle and resolve conflicts and work under stressful conditions.
- Previous experience in purchasing.
Education and Experience: B.S degree in Biology or engineering field or Associate degree in a technical field required with at least 2 years of hands-on experience.
Language Skills: Must be proficient in writing, and communicating in the English language. Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required. Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance.
Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Quality Assurance Specialist
Quality Assurance Specialist at BioGX in Birmingham, AL
Purpose of the Position: Administers/Supports/Facilitates core processes of the Quality Management System (QMS) in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
Essential Duties and Responsibilities (other duties may be assigned):
- Administers/Supports/Facilitates assigned quality related activities within the organization, including but not limited to the maintenance of BioGX’s QMS, supplier performance management, corrective action, preventive action, training management, device & equipment maintenance management and performance monitoring activities required to maintain compliance to QMS requirements.
- Administers/Supports/Facilitates supplier management activities, including supplier selection, evaluation, and re-evaluation. Monitors processes involving the evaluation of purchased components and the dispositioning of purchased components found to be nonconforming in accordance with QMS requirements.
- Administers/Supports/Facilitates approved supplier lists (ASL) and approved material lists (AML).
- Data updating; Review regularly for suitability and accuracy; Self-assessment, survey, nondisclosure agreements (NDA), quality plan agreements (QPA) distribution and follow-up; Update ASL as directed; Process supplier corrective action (SCAR) requests; Maintain supplier related databases and records as assigned
- Administers/Supports/Facilitates document control and procedure development processes in accordance with QMS requirements.
- Administers/Supports/Facilitates corrective and preventive action processes in accordance with QMS requirements.
- Follow-ups through completion; Effectiveness checks
- Administers/Supports/Facilitates equipment management processes to include preventive maintenance and calibration activities in accordance with QMS requirements.
- Administers/Supports/Facilitates compliance monitoring activities to include environmental monitoring, material evaluation and acceptance, product evaluation and acceptance, receipt and disposition of nonconforming material/product, equipment maintenance and calibration, equipment qualification, material and product traceability, material and product identification, risk mitigation, supplier performance monitoring, product realization, record control including good documentation practices and other BioGX processes.
- Administers/Supports/Facilitates with risk management processes and supporting activities.
- Administers/Supports/Facilitates with reviewing and reporting QMS performance objectives and supporting activities.
- Administers/Supports/Facilitates with QMS auditing processes and supporting activities.
- Maintains audit related records
- Ensures all QMS records are complete, legible, protected and retrievable.
- Other duties as assigned.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent verbal and written communication skills
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
- Working knowledge of cGMP, international standards, and Quality Assurance systems.
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software.
- Proficient in typing and keyboard topology.
- Extremely detail-oriented with strong organizational skills and high-quality standards
Education and Experience:
Bachelor of Science Degree from a four-year accredited college or university; or two or more years related experience and/or training.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Good problem solving, judgment and decision-making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Salary: $50,000.00 – $60,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
QMS Manager
QMS Manager at BioGX in Birmingham, AL
Purpose of the Position: Manages core processes of the Quality Management System (QMS) in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”. Uses discretion and independent judgment to fulfill essential duties & responsibilities outlined below.
Essential Duties and Responsibilities:
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
- Responsible for assigned quality related activities within the organization, including but not limited to the maintenance of BioGX’s QMS, corrective action, preventive action, and process performance monitoring activities required to maintain compliance to QMS requirements.
- Manages document control for QMS related documents and procedure development processes in accordance with QMS requirements.
- Manages corrective and preventive action processes in accordance with QMS requirements including follow-ups through completion and effectiveness checks
- Manages equipment management processes to include preventive maintenance and calibration activities in accordance with QMS requirements.
- Performs compliance monitoring activities to include atmospheric monitoring, material evaluation and acceptance monitoring, product evaluation and acceptance monitoring, receipt and dispositioning of nonconforming material/product monitoring, equipment qualification monitoring, material and product traceability monitoring, material and product identification monitoring, risk mitigation monitoring, supplier performance monitoring, product realization monitoring, record control including good documentation practices monitoring and other BioGX process monitoring as needed.
- Manages the reporting of QMS performance objectives and supporting activities. Participates in the regular review of quality objectives and identifies the need for corrective and preventive action.
- Manages QMS auditing processes and supporting activities.
- Monitors and reports on key performance indicators with regards to quality processes to identify the need for corrective and preventive action.
- Ensures that processes needed for the quality management system (QMS) are implemented and maintained in accordance with requirements. Develops and implements strategies to support/maintain compliance to QMS requirements.
- Alternative interface with FDA, Notified Bodies, and Alabama State Department of Health in the event of Company inspections. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities and partners.
- Assists with risk management processes and supporting activities.
- Promotes the awareness of customer requirements. Echoes the importance of meeting customer, statutory and regulatory requirements.
- Brings together staff of different disciplines and drives the group to plan, formulate and agree on comprehensive quality procedures. Communicates with other company personnel to coordinate operations and activities.
- Other duties as assigned.
Supervisory Responsibilities:
Directs and manages subordinate employees working within the department of Quality & Regulatory Affairs as assigned.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent verbal and written communication skills.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
- Working knowledge of FDA’s QSR/cGMP, international standards, and Quality Assurance systems.
- Medical Device industry experience.
- Strong computer skills having advanced knowledge and experience with current word processing, spreadsheet, graphical, and file management software.
- Proficient in typing and keyboard topology.
- Extremely detail-oriented with strong organizational skills and high quality standards
Education and Experience:
Bachelor of Science Degree from a four-year accredited college or university; or five or more years related experience and/or training.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: From $60,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Regulatory Affairs Manager - Remote
Regulatory Affairs Manager at BioGX – Remote Opportunity
***REQUIRED – Please include a cover letter detailing why you are the best candidate for this position.***
Purpose of the Position: Provides leadership, direction and support for the implementation and sustainable initiatives for domestic and international product registrations for BioGX. Serves as the subject matter expert in regulatory & international standards and exercises judgment independently. Ensures effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
The Regulatory Affairs Manager will play a direct role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
Essential Duties and Responsibilities:
- Directly oversees domestic & international submittals and product registrations prescribed by applicable regulatory agencies
- Serve as the Representative who interacts with domestic and international regulatory agencies
- Advises the Sr. Director of Regulatory Affairs on regulatory requirements and changes that affect other functional areas
- Provide guidance to functional areas where needed in order to continually meet evolving regulatory requirements
- Takes all reasonable and prudent measures necessary to maintain regulatory compliance with company and product registration requirements with appropriate notification to, and/or direction from, the Sr. Director, Regulatory Affairs.
- Ensure that processes needed for the quality management system are promulgated throughout the organization
- Develop and implement strategies to support/maintain certification/registrations
- Keeps abreast of changes to quality regulations, standards and guidance documents. Advise management of any business implications of these changes and lead the activities necessary to address the relevant changes
- Lead in the identification, development, implementation and continual improvement of quality systems across the organization. Oversee compliance processes and implement improvements
- Interface with FDA, Notified Bodies, and Alabama State Department of Health in the event of Company inspections. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities and partners
- Participates in company audits with auditing authorities to ensure processes are monitored, measured and analyzed to improve or maintain the effectiveness of the QMS. Implements measurable actions necessary to achieve planned results following audits
- Adheres to good manufacturing practices and good documentation practices
- Some domestic and international travel required
- Exercises independent judgement and decision making
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
Supervisory Responsibilities:
This position does not require supervisory responsibilities at this time.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s Degree required; Master’s Degree preferred
- Five or more years’ experience in a US FDA-regulated manufacturing environment having direct 510(k) and PMA submission expertise
- Strong knowledge of and a minimum of 5 years’ experience with ISO 13485 international standards, FDA 21CFR820, In-Vitro Diagnostic Directive (IVDD), In-Vitro Diagnostic Regulation (IVDR), and quality management systems
- Excellent written and verbal communication skills
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word/Good Docs), spreadsheet (MS Excel/Google Sheets), graphical, and file management software
- Proficient in typing and keyboard topology
- Extremely detail-oriented with strong planning and organizational skills
- Self driven
- Able to work without supervision
Education and Experience:
A diploma, certificate or other evidence of formal qualification, awarded on completion of an accredited university degree in law, medicine, engineering or another relevant scientific discipline. At least four years of professional experience in regulatory affairs in the area of medical devices.
Experience:
- FDA 21CFR820: 5 years (Required)
- In-Vitro Diagnostic Directive (IVDD),: 5 years (Required)
- ISO 13485 international: 5 years (Required)
- In-Vitro Diagnostic Regulation (IVDR): 5 years (Required)
- Regulatory Affairs: 5 years (Required)
- Quality Management Systems: 5 years (Required)
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Excellent problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while sitting or standing. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.
Job Type: Full-time
Pay: $90,000.00 – $130,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Research Associate
Research Associate at BioGX – Birmingham, AL
Purpose of the Position: The position executes a range of molecular biology procedures, reagent preparation, bioanalytical procedures, and laboratory duties under supervision. Performs laboratory duties while maintaining associated health and safety guidelines, and is also responsible for maintaining inventory of laboratory reagents and supplies.
Essential Duties and Responsibilities (other duties may be assigned):
- Responsible for the day-to-day running of experiments and data analysis in the research and development laboratory.
- Responsible for carrying out work to company standards, including documentation, accurate record keeping, and maintaining related work schedules in order to support product development timelines.
- Prepares reagents and solutions as directed, using appropriate procedural and documentation methods, including industry standard good laboratory practices.
- Performs experiments and data analysis under supervision.
- Analyze, record, and compile experimental results and reports in laboratory notebook.
- Present results at meetings as required, and proposes new strategies and methods to address immediate and upcoming technical issues.
- Responsible for maintaining R&D stockroom supplies and inventory.
- Implements the company’s health and safety policies and procedures.
- Interacts with other internal departments, as necessary, to plan and expedite project objectives.
- Provides scientific support to permit completion of development and technology transfer objectives for molecular diagnostics products.
Supervisory Responsibilities: None
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Minimum 1 yr molecular biology or biochemistry laboratory experience post-B.S. degree
- First hand experience with assay formatting and development, biological sample handling, nucleic acid purification, molecular biology methods and techniques including PCR, PAGE/agarose electrophoresis
- Excellent written and oral communication skills with ability to present data and results
- Excellent skills with Microsoft Word and Excel
Education and Experience: The ideal candidate will have a B.S. degree in Chemistry, Biochemistry, Molecular biology or related field with 2 or more years of laboratory experience. Experience as Medical Laboratory Technician is desirable.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with B.S. level education
Reasoning Ability: Good problem solving, judgment and decision making skill are required.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench, or automated instrumentation. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $35,000.00 – $45,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Research and Development Manager
Research and Development Manager at BioGX in Birmingham, AL
***REQUIRED – Please include a cover letter detailing why you are the best candidate for this position.***
Purpose of the Position:
The primary purpose of this position is to manage Product Development functions at BioGX, Birmingham, AL. Primary responsibilities:
1) The Research and Development Manager is responsible for managing the completion of the research and development activities of new products, product enhancements, product improvements and product transfer. Evaluates the potential and practicality of products in development and relies on experience and judgment to plan and accomplish goals.
2) Working in a design control environment, provides scientific expertise, project management skills, application of knowledge of ISO13485, CE-IVDR, and FDA regulations to ensure product design and development documentation and processes adhere to BioGX standards and governing regulations.
Possesses and applies a broad knowledge of principles, practices and procedures of field. Demonstrates product and scientific content leadership with internal and external customers. Stays current on research developments and new concepts in molecular diagnostics, giving test design perspective to sales and marketing activities associated with current or new products. Experienced with ISO 13485, CE-IVDR, and FDA QA standards and Design Control functions.
Essential Duties and Responsibilities (other duties may be assigned):
- Manage the development of BioGX real time PCR products.
- Manage Research and Development staff.
- Manage ongoing Research and Development projects.
- Manage and plan future Research and Development configurations through project scheduling, resource allocation, and materials procurement.
- Manage product development from feasibility testing to product transfer using existing Design Control procedures
- Writing, reviewing, and editing of QMS processes and procedures as they relate to R&D.
- Review and approve/reject Product Transfer Documents (PTDs) for compliance with specifications, accuracy and completeness.
- Participate in and coordinate external and internal validation/clinical site studies and sample procurement activities.
- Ensure research and development activities are completed with adherence to regulatory requirements.
- Provide scientific expertise for Regulatory and Marketing and Sales activities associated with product launches.
- Ensures adherence to schedules and work plans.
- Provides tactical updates to R&D leadership.
- Communicates and collaborates cross-functionally to achieve program goals. Review and present project progress to the Sr. Dir., of Product Development.
Supervisory Responsibilities: Manage R&D scientists to achieve objectives. Manage staff growth and development.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Specialized knowledge and experience in molecular diagnostics and real-time PCR is required. Supervisory experience at junior to senior scientist levels.
- Specialized knowledge and experience in molecular diagnostics and real-time PCR is required. Supervisory experience at junior to senior scientist levels.
- Excellent verbal and written communication skills.
- Design control, product development and launch experience.
- Performance management experience.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in IVD business.
- Working knowledge of cGMP and Quality Assurance systems used in IVD products.
- Practical experience with clinical investigations during research, development, and validation stages, the latter in support of impending regulatory submissions (510k, PMA, etc.).
- Demonstrated familiarity with relevant publications, patents and processes leading to such.
Education and Experience:
Ph.D. degree is required with 5 years of experience in the field, or Masters Degree with at least 10 years of direct experience working in Molecular Diagnostics area is required.
Language Skills: Must be proficient in writing, and communicating in the English language. Mathematical Skills: Must be consistent with Master’s Degree level education. Reasoning Ability: Good problem solving, judgment and decision making skills are required. Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $80,000.00 – $110,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Scientist, Research and Development
Scientist, Research and Development at BioGX – Birmingham, AL
Purpose of the Position: Perform laboratory research to develop multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select target sequences of interest, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements.
Essential Duties and Responsibilities (other duties may be assigned):
- Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of development problems associated with genetic tests for the presence of specific DNA and RNA sequences.
- Supervises R&D staff, works in laboratory, participates on product transfer teams.
- Carries out design of experiments (D.O.E.) studies needed to establish robust PCR-based genetic test performance and uses experimental results to develop raw material requirements, product performance specifications, product packaging requirements, stability characteristics, and product’s manufacturing release test criteria.
- Carries out feasibility and development experiments, protocols, procedures, and report writing supporting product development for timely completion of project(s).
- Maintains current knowledge of competitive technologies, new principles and theories relevant to product R&D and commercialization.
- May train, motivate, and develop R&D staff.
- Document experimental protocols, results of studies and process design/development history to meet QMS requirements.
Supervisory Responsibilities: Supervise one or more Research Associates depending upon project scope.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience of nucleic acid, PCR-based diagnostic test product development experience.
- Experienced with DNA and RNA sample processing and sample stabilization procedures, and with BSL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures.
- Well organized and efficient with handling multiple tasks at the same time.
- Technician supervisory experience.
- Experienced with short, intermediate and longer term project planning and clinical research.
- Fluent in the use of Microsoft Word, Excel, PowerPoint.
- Excellent written and verbal communication skills.
- Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
- Ability to handle and resolve conflicts and work under stressful conditions.
Education and Experience: The ideal candidate will have a Ph.D. or equivalent degree in Chemistry, Molecular Biology or related field. Additional field experience (5 to 10 years) is important to succeed in the job function. Master’s (Required)
Experience: Real-Time PCR: 1 year (Required)
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $65,000.00 – $90,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Team Lead, Manufacturing
Team Lead, Manufacturing at BioGX in Birmingham, AL
Purpose of the Position:
The Manufacturing Team Lead will lead manufacturing Packaging & Shipping staff by organizing and monitoring work-flow, planning schedules, resources, product QC release and shipping.
Essential Duties and Responsibilities (other duties may be assigned):
- Accomplishes manufacturing Packaging & Shipping staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
- Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities.
- Maintains work flow by monitoring steps of the process; setting processing variables; observing control points and equipment; monitoring personnel and resources; studying methods; developing reporting procedures and systems; initiating and fostering a spirit of cooperation within and between departments.
- Completes production Packaging & Shipping plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results of the processing flow on shift production summaries.
- Maintains quality standards by establishing and enforcing quality systems compliance and process improvements.
- Provides manufacturing information by compiling, initiating, sorting, and analyzing production performance records and data; answering questions and responding to requests.
- Creates and revises processes and procedures by analyzing operating practices, recordkeeping systems, forms of control, implementing change in QMS.
- Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
- Resolves personnel concerns by analyzing data; investigating issues; identifying solutions; recommending action.
- Maintains professional and technical knowledge by attending educational workshops as required.
- Contributes to team effort by accomplishing related results as needed.
- Understand, train personnel, and enforce strict adherence to the applicable quality and manufacturing operating procedures, company policy, and defined customer requirements.
- Assist in attaining quarterly and annual production goals.
- Learn and enforce company safety policies and practices.
- Lead and/or support Lean Manufacturing initiatives.
- Other duties as assigned.
Supervisory Responsibilities:
- Responsible for the coordination and supervision of Manufacturing Packaging & Shipping staff.
- Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and coordinate training of employees; planning, assigning, and supervising work; rewarding and disciplining employees; addressing complaints and resolving personnel conflicts and problems.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Excellent verbal and written communication skills
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.
- Working knowledge of cGMP, international standards, and Quality Assurance systems.
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software.
- Proficient in typing and keyboard topology.
- Extremely detail-oriented with strong organizational skills and high quality standards
Education and Experience: B.S. science or engineering or related discipline with at least 2 years leadership experience in an FDA/ISO regulated manufacturing environment.
Language Skills: Must be proficient in writing, and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Good problem solving, judgment and decision making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay:
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Technical Support Specialist - Dallas
Technical Support Specialist at BioGX in Dallas, TX
Purpose of the Position: Responsible for providing technical support to BioGX customers and distributors including data analyses for all of BioGX product lines. The Technical Support Specialist also provides support to Molecular Application Specialists, Field Service Engineers and Territory Sale Executives. Perform excellent customer service, advanced administrative, company reporting and technical support operations for BioGX using excellent organizational skills, phone etiquette, written and verbal communication skills, and PC/cloud-based software application knowledge.
Essential Duties and Responsibilities (other duties may be assigned):
- Provides phone and e-mail support.
- Documents customer reported complaints in the complaint management system.
- Follows procedures to ensure adequate complaint handling into call tracking database.
- Conducts preliminary investigation and data collection for technical problems of diverse scope.
- Escalates complaints to Product Support/Management team as necessary.
- Represents Technical Support in project and/or operations teams and communicates contributions and findings back to Product Support.
- Update and maintain processes, records and files, which may contain confidential information.
- Maintain confidentiality and high-level information under strict confidence.
- Receive customer POs and assist in the coordination of order flow fulfillment activities with manufacturing.
- Follow-up on deliveries when assigned.
- Assists with pick, pack and shipping activities.
- Perform and maintain job functions in compliance with QMS standards and regulatory affairs.
- Performs additional tasks as assigned.
Supervisory Responsibilities: N/A
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Relevant experience in Biochemistry/Molecular Biology.
- Customer Service experience.
- Product marketing experience.
- Good understanding and ability to follow complex procedures and processes.
- Extensive experience with real-time PCR.
- Knowledge of molecular diagnostics.
- Knowledge and application of commercial computer application packages (G-Suite, MS Office, IE, etc.).
- Knowledge of CRM software.
- Excellent written and verbal communication skills.
- Outstanding troubleshooting and problem-solving skills.
- Thrives in dynamic, fast-paced, and constantly changing environment.
- Self-motivated, organized, and with strong attention to detail.
- Flexible to work different shifts, weekends, and holidays as necessary.
Education and Experience: Bachelors in Biochemistry or Molecular Biology.
Language Skills: Must be proficient in writing, and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level of education. Good problem solving, multi-tasking, judgment and decision making skills are required.
Reasoning Ability: Good problem solving, judgment and decision making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Certifications, Licenses, Registrations: N/A
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work will require travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood Bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $50,000.00 – $60,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
