The Senior Microbiologist is responsible for executing complex microbiological assays and limit tests while ensuring strict compliance with cGMP regulations and safety standards. This role provides technical leadership through method validation, laboratory investigations, and the mentorship of junior staff to support the Quality Laboratory's operational goals. Po
- Perform microbiological assay of Cyanocobalamin (B12), Folic Acid, Niacinamide, Biotin and Pantothenic Acid on finished products.
- Conduct Sterility Testing and Bacterial Endotoxin Testing (BET) to ensure product safety and compliance with pharmacopeial standards.
- Execute Antimicrobial Effectiveness Testing (AET) to evaluate preservative efficacy in multi-dose formulations.
- Conduct comprehensive microbiological limit tests per USP and USP .
- Manage environmental monitoring programs, including the collection and trend analysis of water, swab, and air samples.
- Oversee the maintenance, culturing, and freezing of live microbiological agents and molds used in suitability studies.
- Utilize, maintain, and troubleshoot critical instrumentation, including Steritest units, LAL Kinetic readers, microscopes, autoclaves, incubators, and biological safety cabinets (BSC).
- Author standard operating procedures and microbiological methods.
- Perform and document thorough laboratory investigations for deviations or out-of-specification (OOS) results.
- Perform and document work in compliance with standard operating procedures, cGMP regulations, and applicable laboratory safety standards.
- Review laboratory notebooks for accuracy, completeness, and adherence to cGMP standards. Execute and/or assist with equipment calibrations, qualifications (IQ/OQ/PQ), method validations, and method transfers.
- Perform method validations, method transfers, and method troubleshooting.
- Assist laboratory management in preparation for internal, customer and agency audits.
- Train and guide new colleagues on laboratory protocols and aseptic techniques.
- May be responsible for specific areas, functions, projects, and/or instrumentation based on experience and expertise.
- Other related duties as required.
QUALIFICATIONS:- Bachelor's degree in microbiology or closely related discipline.
- 8+ years' experience in microbiological and/or chemistry laboratory.
- 8+ years' experience with aseptic technique and use of microbiological test methods.
- Demonstrate a strong commitment to being a team player by actively collaborating with cross-functional colleagues, sharing technical knowledge, and maintaining a positive work environment to achieve collective laboratory goals.
- Deep understanding of cGMP regulations, laboratory safety standards, and instrumentation troubleshooting.
- Strong communication skills, both written and verbal.
- Exceptional attention to detail and ability to follow complex SOPs.
- Ability to prioritize and manage concurrent tasks with minimal supervision.
- Desire to work in a positive team environment.
