Biogen · 2 months ago
Sr. Manager, Quality Control - Microbiology (Biologics)
Triangle, NC
Full-time
Onsite
Senior Level
$120K/yr - $161K/yr
7+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. They are seeking a Senior Microbiology Manager to lead the microbiology function at their biologics drug substance manufacturing facility, ensuring microbiological integrity and compliance with regulatory standards.
BiotechnologyHealth CareNeuroscienceTherapeutics
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
Qualification
Required
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
Experience with cell culture, fermentation, purification
Familiarity with rapid microbiological methods (RMM) and modern analytical technologies
Experience developing contamination control strategies
Experience managing projects
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
Pharmaceutical Technology
2026-01-05
Company data provided by crunchbase