Sr. Manager, Quality Control - Microbiology; Biologics

Position: Sr. Manager, Quality Control - Microbiology (Biologics)
Sr. Manager, Quality Control - Microbiology (Biologics)

Join to apply for the Sr. Manager, Quality Control - Microbiology (Biologics) role at Biogen

Sr. Manager, Quality Control - Microbiology (Biologics)

Join to apply for the Sr. Manager, Quality Control - Microbiology (Biologics) role at Biogen

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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.

Required Skills

• 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

Preferred Skills

• Experience with cell culture, fermentation, purification
• Familiarity with rapid microbiological methods (RMM) and modern analytical technologies
• Experience developing contamination control strategies
• Experience managing projects

Job Level: Management

Additional Information

The base compensation range for this role is: $-$

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

Benefits

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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…