Job Title: Senior Scientist, Microbiology
Location: Brookhaven, NY, United States
Company: Amneal Pharmaceuticals
Job Category: Microbiology
Job Schedule: Full-time
Company Overview
Amneal Pharmaceuticals is a global pharmaceutical company committed to developing and delivering high-quality medicines. The company emphasizes compliance with cGMP standards and a culture of safety, innovation, and professional growth.
Job Overview
The Senior Scientist, Microbiology is responsible for microbiological testing of raw materials, in-process, finished, and stability samples, as well as performing scheduled environmental monitoring. The role ensures compliance with cGMP, SOPs, and analytical procedures, reviews and approves laboratory records, and participates in method validations, investigations, and special projects.
Key Responsibilities
Microbiological Testing & Validation
Test raw materials, in-process samples, finished products, and stability samples for microbial qualitative and quantitative testing.
Perform tests according to USP, in-house methods, and compendial procedures for Total Aerobic Count, Total Yeast & Mold Count, and specified organisms (e.g., E. coli, Salmonella spp., S. aureus, P. aeruginosa).
Conduct preservative challenge tests and other R&D-related projects as required.
Sample and test purified water for heterotrophic counts and coliforms.
Perform environmental monitoring and cleaning validation of manufacturing facilities.
Documentation & Compliance
Review, approve, and maintain laboratory records (notebooks, computer-based).
Document deviations (Microbial Data Deviation, MDD) and report discrepancies to laboratory management.
Execute protocols for method verifications, validations, and special projects.
Ensure compliance with cGMP, SOPs, and regulatory standards.
Laboratory Operations & Equipment
Prepare and dispense culture media; sterilize glassware and laboratory items.
Perform QC checks on prepared media, equipment, and autoclaves, including bioindicator checks and temperature verification.
Decontaminate used/contaminated objects and ensure expired chemicals or media are replaced.
Verify calibration status of instruments and usability of reference standards.
Training & Leadership
Provide hands-on training to new laboratory technicians and scientists.
Occasionally lead laboratory activities and special projects.
Assist supervisors with non-routine or high-priority tasks as needed.
Qualifications & Experience
Education:
Required: Bachelor’s Degree (BA/BS) in Microbiology or related field
Preferred: Master’s Degree (MS/MA) in Microbiology or related field
Experience:
5+ years of microbiological testing in a regulated pharmaceutical environment (with Bachelor’s).
3+ years of microbiological testing in a regulated pharmaceutical environment (with Master’s).
Skills:
Precision, consistency, and ability to follow analytical/microbiological procedures.
Strong communication skills (verbal and written) for reporting results and issues.
Ability to work in a team, provide training, and adapt to changing priorities.
Proficient in computer applications relevant to laboratory operations.
Knowledge of cGMP, aseptic techniques, method validation/verification, and preservative challenge tests.
Ability to troubleshoot complex analytical and instrument-related issues.
Maintain clear and compliant laboratory documentation.
Specialized Knowledge:
Microbiological methods, handling sterile media and organisms, avoiding contamination.
Compendial procedures (USP/EP/JP/BP) and analytical techniques.
Ability to analyze trends in microbiological data.
Salary & Benefits
Base salary range: $90,000 – $120,000 per year
Competitive benefits including health insurance, 401(k) matching, and flexible options for work-life balance.
Opportunities for professional growth and development in a regulated, high-quality environment.
Equal Opportunity
Amneal is an Equal Opportunity Employer and does not discriminate based on sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, or any other protected characteristic under applicable laws.
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