Scientist II (Microbiology)

About the Role

A Scientist II in Quality Control Microbiology demonstrates advanced knowledge in microbiological test methods and instrumentation, and guides others in routine test methods. This role involves mentoring and training less experienced analysts across four main functional groups within the QC Microbiology department.

Responsibilities

• Understand department priorities and plan accordingly.
• Perform peer review of data for accuracy, completeness, and conformance to specifications.
• Communicate work-related issues clearly and effectively to management and peers.
• Maintain knowledge of cGMPs, GLPs, and current compendial methods.
• Teach or coordinate training modules and laboratory techniques for new analysts.
• Assist in authoring basic investigative studies (OOS, OOT, OOL) and other necessary documents.
• Support senior personnel in projects, investigations, special testing, and project work.
• Investigate deviations from SOP requirements and nonconforming test results, including environmental monitoring, to determine root cause and corrective actions.
• Identify additional testing required to resolve issues in a timely manner.
• Generate and update SOPs for microbiology test procedures and train new personnel.
• Ensure adherence to safety policies and recommend improvements.
• Maintain and calibrate equipment not handled by metrology or maintenance departments.

Environmental Monitoring

• Schedule, initiate, coordinate, and perform routine and non-routine environmental monitoring.
• Assess environmental conditions using various sampling methods for environment, water systems, compressed gas, and personnel.
• Recognize out-of-limit results and initiate OOL investigations.
• Achieve and maintain ISO Class 5 gowning certification.
• Process paperwork, LIMS input, and approvals for release by QA.
• Investigate environmental OOL excursions and coordinate responses.
• Maintain laboratory areas, environmental chambers, and inventory of test media and reagents.
• Complete microbial identification activities, including sub-culture, Gram staining, and culture maintenance.
• Train manufacturing personnel in aseptic and gowning techniques.
• Coordinate timely completion of routine and project testing.
• Process data for critical systems release and escalate unexpected results.

Finished Products Testing

• Schedule, initiate, coordinate, and perform routine testing of in-process, finished product, and raw materials.
• Coordinate and collect samples for annual component testing requirements.
• Ensure timely testing and reporting of stability samples.
• Conduct environmental monitoring during bioburden and sterility testing (SKAN isolators).
• Complete microbial identification activities, including sub-culture, Gram staining, and culture maintenance.
• Maintain testing equipment and coordinate requalification, preventive maintenance, and calibration.
• Process paperwork, LIMS input, and approvals for release by QA.
• Provide data for annual product reviews, investigational requests, and validation studies.

Validations

• Develop and validate microbiological test methods for new products, including APIs, in-process, and finished products.
• Perform studies to support new product introductions, including method justifications for stoppers, vials, PFBB validation, and raw material bioburden/Bacterial Endotoxin validations.
• Conduct routine testing of in-process and finished product samples for exhibit/process validation batches.
• Review and approve testing results within the department.
• Write and revise standard operating procedures (SOPs).
• Develop study protocols to validate production and laboratory methods.
• Support plant and lab equipment requalification studies and Tech Transfer’s process validation protocols.
• Perform microbiological testing for product process validation studies.

Bacterial Filter Retention (BFR) Laboratory

• Author and execute BFR study protocols to validate sterilizing grade filters used in manufacturing aseptic fill processes.
• Perform routine testing of validation activities, including viability, spike-flush, and filter compatibility studies.
• Prepare microbial suspensions, media, and reagents as needed.
• Monitor environmental conditions in the laboratory.
• Review and approve testing results of peer work.
• Assist with laboratory qualification and requalification studies.
• Review SOP updates related to BFR.
• Investigate nonconforming test results for validation impact, root cause, and derive applicable CAPAs.
• Maintain laboratory equipment and coordinate preventive maintenance, calibration, and requalification.

Pay

Hourly range: $29.31 - $41.20. Final pay determinations depend on factors including experience level, education, knowledge, skills, and abilities.

Benefits

• 401(k) plan with company contributions.
• Paid vacation, holiday, and personal days.
• Employee assistance program.
• Health benefits including medical, prescription drug, dental, and vision coverage.
• Life insurance and disability coverage.
• Wellness program.