Senior Microbiology Analyst

Senior Microbiologist – Glenmark Pharmaceuticals

The Senior Microbiologist is a critical technical resource in the QC Microbiology laboratory supporting the manufacturing of sterile injectable products. The role independently performs and oversees complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA, and internal quality standards. The position operates in a fast‑paced, FDA‑regulated pharmaceutical environment and is responsible for deviation investigations, OOS/OOT, and CAPA development related to EM and microbiological testing.

The Senior Microbiologist maintains spreadsheets and databases to track department data, KPIs, and metrics, manages QC Microbiology inventory, and serves as a subject‑matter expert to guide and train junior microbiologists.

• Perform and oversee complex microbiological testing and environmental monitoring in compliance with cGMP, USP, FDA, and company standards.
• Investigate deviations, OOS/OOT events, and develop CAPAs for EM and microbiological testing.
• Maintain and update spreadsheets and databases for departmental metrics, test data, and inventory.
• Manage QC Microbiology inventory, order and stock materials, and resolve material complaints.
• Train team members in aseptic technique, microbiological methods, EM sampling, and good documentation practices.
• Participate in qualification and validation of microbiology laboratory equipment and methods.
• Identify and implement continuous improvement opportunities to optimize laboratory workflows.
• Ensure laboratory equipment compliance with procedures and GLP requirements.
• Troubleshoot laboratory instrumentation issues and recommend corrective actions.
• Perform GMP review of test data to ensure compliance with specifications and analyze trends to mitigate equipment and reagent performance issues.

• Prepare, review, and approve sampling matrix and hold‑time schedules.
• Communicate lab investigation results when test results fall outside specifications.
• Maintain spare parts inventory, calibrations, and supervise third‑party maintenance when necessary.
• Establish good working relationships with contract laboratories.
• Support method transfer, validation, cross‑validation, and IQ/OQ/PQ protocols.
• Assist with vendor certification program activities and supplier audits.
• Conduct statistical evaluation of manufacturing and inspection processes and train QC staff.
• Ensure all equipment is calibrated and validated new test procedures.
• Compile data and generate reports for management review.
• Review lab test data for integrity and adherence to SOPs and cGMP.

• Maintain current knowledge of regulatory and industry standards, trends, and advancements.
• Ensure EM/Microbiology laboratory and cleanroom areas comply with systems and procedures and prepare for audits.
• Support continuous improvement initiatives by updating SOPs, work instructions, and OJT.
• Maintain certified investigator training and certify as a trainer.
• Apply root‑cause analysis tools to investigate quality events and initiate CAPAs.
• Ensure Quality Systems compliance with cGMP, internal, and external regulations.
• Assist in implementing new changes at the site, including training on a needs‑basis.
• Prepare EMPQ reports, EM trend reports, and QMR board presentations with supporting documentation.
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Perform regular self‑audits of microbiology and EM laboratory areas and address audit findings.

• Support purchasing of QC EM laboratory supplies and make decisions to optimize available funds.
• Consult with management on laboratory supply variances and prepare realistic plans to address supply‑chain issues.
• Maintain QC department ordering system to reduce costs and waste due to expiry.
• Keep up‑to‑date on physical and computerized tracking systems for materials and supplies.

• Appropriately use PPE as required for laboratory duties.
• Lift up to 30 lbs and work in varying temperature and humidity environments.

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, or Biology.
• Minimum 3+ years of experience in a pharmaceutical environment.
• Strong organizational, prioritization, and multi‑tasking skills.
• Excellent written and technical communication skills; proficient in root‑cause analysis tools (e.g., 5 Whys, Pareto Analysis, 5M+E).
• Strong interpersonal skills and ability to work with all organizational levels.
• Ability to read, understand, and execute SOPs and achieve Glenmark's QE investigator certifications.
• Analytical and problem‑solving skills with proven laboratory issue resolution.
• Knowledge of safety and environmental risk assessment in compliance with the EHS management system.
• Capacity to work independently and as part of a team on multiple projects with changing priorities.