BioGX is a global molecular diagnostics company focused on the health and safety of communities all over the world. We design, develop and manufacture products and devices for Clinical, Water Quality, Food Safety and Pharma Quality. We are headquartered in Birmingham, AL.
The Purpose of the Position:
The Reagent Production Associate I is responsible for general laboratory duties focused on manufacturing of standards, controls and panels for commercially available nucleic acid tests and other advanced reagents. The Reagent Production Associate I is expected to follow standard operating procedures and quality systems documentation.
Essential Duties and Responsibilities (other duties ma assigned):
● Coordinates and executes reagent manufacturing procedures
● Compiles and submits manufacturing batch records for manufacturing’s review and QC testing
● 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 manufacturing
● Assists in inventory management and ordering materials
● Assists in the development of reagent manufacturing processes and documentation
● Assists in maintaining production and laboratory equipment
● Assists in the development of physical quality specifications and tests
● Assists in testing raw materials for reliability and stability
● Assists in transferring processes from development to manufacturing
● Performs job functions in compliance with QMS standards.
● Supports continuous quality improvement
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)
● Strong technical skills, including a working understanding of molecular biology and biochemistry
● Demonstrated analytical, troubleshooting, and problem solving skills
● 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:
B.S./M.S. in molecular biology or related field with at least 2 years of hands-on experience in reagents manufacturing.
Language Skill: 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. Google Suite
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.