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
Additional Information
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.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
