Research and Development Scientist

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 and summarization of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements.

This role is being advertised in anticipation of future staffing needs. Applications will be reviewed on a rolling basis, and candidates may be contacted when the position becomes active.

• 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 Associates, 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, using Good Documentation Practices and clear and professional 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 / Associate Scientists depending upon project scope.

• Experience of nucleic acid, PCR‑based diagnostic test product development.
• Experienced with DNA and RNA sample processing and sample stabilization procedures.
• Experienced with BSL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures.
• 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.
• Excellent written and verbal communication skills.
• Work seamlessly 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.

• Ph.D. or M.S. (plus 2 to 5 years experience) degree in Microbiology, Molecular Biology or related field.
• Direct experience with Real‑Time qPCR is desirable.