Sr. Manager, Quality Control - Microbiology (Biologics)
About The Position
This position will work M-F business hours, plus weekend on-call support About This Role We are seeking a highly experienced and motivated Senior Microbiology Manager to lead the microbiology function at our state-of-the-art biologics drug substance manufacturing facility. This role is critical to ensuring the microbiological integrity of our processes, utilities, and environment, and plays a key role in supporting GMP compliance and product quality. What You’ll Do Lead and manage the site microbiology team, including hiring, training, and performance management Oversee environmental monitoring (EM), utility monitoring (WFI, clean steam, compressed gases), and microbiological testing of raw materials, in-process samples, and drug substance Develop and maintain microbiological control strategies for aseptic and non-aseptic manufacturing areas Provide technical leadership in contamination control, risk assessments, and deviation investigations Ensure compliance with global regulatory requirements (FDA, EMA, ICH, etc.) and internal quality standards Support regulatory inspections and audits as the subject matter expert (SME) for microbiology Drive continuous improvement initiatives in microbiological methods, EM programs, and contamination control Collaborate cross-functionally with Manufacturing, Quality Assurance, Validation, and Engineering teams Who You Are You are a strategic thinker with a deep understanding of microbiology in a GMP-regulated biologics environment, and a confident leader who inspires and develops high-performing teams. You are detail-oriented and analytical, with a strong commitment to data integrity and quality, and comfortable making decisions in a fast-paced, dynamic environment.
Requirements
- Bachelor’s degree in Microbiology, Biology, or related field (Master’s preferred)
- Minimum 7 years of experience in microbiology within a GMP-regulated biologics manufacturing environment (or combination of pharmaceutical and biologics)
- Minimum of 5 years of experience managing Quality Control laboratories, including oversight of method validation and method transfer activities
- Strong knowledge of aseptic processing, cleanroom classifications, and environmental monitoring programs
- Experience with regulatory inspections and audit readiness
- Proven leadership and team management skills
- Excellent communication, problem-solving, and organizational abilities
Nice To Haves
- Experience with cell culture, fermentation, purification
- Familiarity with rapid microbiological methods (RMM) and modern analytical technologies
- Experience developing contamination control strategies
- Experience managing projects
Responsibilities
- Lead and manage the site microbiology team, including hiring, training, and performance management
- Oversee environmental monitoring (EM), utility monitoring (WFI, clean steam, compressed gases), and microbiological testing of raw materials, in-process samples, and drug substance
- Develop and maintain microbiological control strategies for aseptic and non-aseptic manufacturing areas
- Provide technical leadership in contamination control, risk assessments, and deviation investigations
- Ensure compliance with global regulatory requirements (FDA, EMA, ICH, etc.) and internal quality standards
- Support regulatory inspections and audits as the subject matter expert (SME) for microbiology
- Drive continuous improvement initiatives in microbiological methods, EM programs, and contamination control
- Collaborate cross-functionally with Manufacturing, Quality Assurance, Validation, and Engineering teams
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
