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.

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 Location: Birmingham, AL