Associate Director, QC Microbiology
$180,000–$205,000 year
On-site · Emeryville, California, United States
Job Summary
The Associate Director of QC Microbiology leads the microbiology quality control organization in a GMP-regulated CDMO, overseeing environmental monitoring, water/utility monitoring, bioburden, endotoxin, sterility, growth promotion, microbial identification, and aseptic process support. Responsibilities include ensuring data integrity and timely review of data, deviations, CAPAs, OOS/OOT investigations, and lab documentation; maintaining inspection-ready operations per FDA/EMA/ICH/USP/EU GMP Annex 1 and 21 CFR Part 11; leading audits, regulatory responses, and customer inquiries; driving continuous improvement, technology transfers, and lifecycle management of microbiological assays; managing staffing, budgeting, KPIs, and resource planning; collaborating with Manufacturing, QA, MSAT, Validation, and Engineering; leading root-cause investigations of microbial excursions; and supporting method validation/transfer and rapid microbiological methods while advancing digitalization and LIMS utilization.
Required Qualifications
- Bachelor’s degree in Microbiology, Biology, Biochemistry, or related scientific discipline required.
- 10+ years of progressive QC Microbiology or pharmaceutical microbiology experience in biologics, biotechnology, or sterile pharmaceutical manufacturing environments.
- Minimum 5 years of leadership or people management experience.
- Strong knowledge of Environmental monitoring programs, Aseptic processing, Sterility assurance, Cleanroom operations, Utility systems, Contamination control strategies, USP microbiological methods, GMP documentation practices.
- Experience with monoclonal antibodies, recombinant proteins, or biosimilars manufacturing preferred.
- Experience within a CDMO environment strongly preferred.
- Direct experience supporting regulatory inspections and customer audits required.
Desired Qualifications
- Strong knowledge of environmental monitoring programs
- Aseptic processing
- Sterility assurance
- Cleanroom operations
- Utility systems
- Contamination control strategies
- USP microbiological methods
- GMP documentation practices
- Familiarity with rapid microbiological technologies and automated systems
- Experience with LIMS, TrackWise, Empower, MODA, or similar systems desirable
- Strong technical writing, investigation, and risk assessment skills
- Strategic leadership
- Technical problem-solving
- Regulatory compliance mindset
- Cross-functional collaboration
- Decision-making under pressure
- Strong communication and presentation skills
- Continuous improvement orientation
- Customer-focused mindset
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