Sr. Manager, Quality Control - Microbiology (Biologics)

Biogen, Inc.; North Carolina; On-site; USD 120,000 - 161,000; Full time

Job summary

Biogen, Inc. is seeking a Senior Manager for Quality Control in Microbiology at their Research Triangle Park facility. This leadership role involves managing a microbiology team, overseeing compliance with GMP standards, and ensuring product quality through rigorous microbiological testing. The ideal candidate will have significant experience in a biologics manufacturing environment and strong leadership skills to drive contamination control and continuous improvement initiatives. Competitive salary and benefits package included.

Benefits

Medical, Dental, Vision, & Life insurances

Fitness & Wellness programs

Paid Maternity and Parental Leave

Tuition reimbursement of up to $10,000 per year

Qualifications

• Minimum 7 years of experience in microbiology within a GMP-regulated biologics manufacturing environment.
• Minimum of 5 years of experience managing Quality Control laboratories.
• Strong knowledge of aseptic processing and environmental monitoring programs.

Responsibilities

• Lead and manage the site microbiology team.
• Oversee environmental monitoring and microbiological testing.
• Ensure compliance with global regulatory requirements.

Skills

Leadership

Microbiology expertise

Analytical skills

Education

Bachelor's degree in Microbiology, Biology, or related field

Master's degree (preferred)

Job description

Sr. Manager, Quality Control - Microbiology (Biologics) page is loaded

Sr. Manager, Quality Control - Microbiology (Biologics)

Apply remote type On Campus locations Research Triangle Park, NC time type Full time posted on Posted Yesterday job requisition id REQ21230

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: $120,000.00-$161,000.00

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.

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 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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Perks of Biogen

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.

Caring Deeply. Achieving Excellence. Changing Lives.