Sr. Manager, Quality Control - Microbiology (Biologics) job opportunity at Biogen Inc..

_{More Than 30 Days Ago} bot

Biogen Inc. Sr. Manager, Quality Control - Microbiology (Biologics)

Experience: 7-years

Pattern: full-time

Country:

Apply Now

Salary:

Status:

Quality Control - Microbiology (Biologics)

Copy Link Report

General

Research Trian..........United States Of America

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.

Other Ai Matches

Senior Medical Director, Global Medical Device Applicants are expected to have a solid experience in handling Global Medical Device related tasks

Remote

Clinical Operations Program Lead Applicants are expected to have a solid experience in handling Job related tasks

Business Analysis Lead Applicants are expected to have a solid experience in handling Job related tasks

Duales Studium Betriebswirtschaftslehre - Gesundheitsmanagement Applicants are expected to have a solid experience in handling Job related tasks

Head of Commercial & Medical Field Excellence Applicants are expected to have a solid experience in handling Job related tasks

Sr. Manager, Global Regulatory Affairs Applicants are expected to have a solid experience in handling Global Regulatory Affairs related tasks

EU CTR Submission Group Lead Applicants are expected to have a solid experience in handling Job related tasks

Facilities Technician II Applicants are expected to have a solid experience in handling Job related tasks

Co-op, Manufacturing Sciences Applicants are expected to have a solid experience in handling Manufacturing Sciences related tasks

Principal Clinical RBQM Programmer Applicants are expected to have a solid experience in handling Job related tasks

Co-op, Quality Engineering Applicants are expected to have a solid experience in handling Quality Engineering related tasks

Medical Director, SMA & ALS - US Medical Affairs Applicants are expected to have a solid experience in handling SMA & ALS - US Medical Affairs related tasks

Co-op, Immunobiology Applicants are expected to have a solid experience in handling Immunobiology related tasks

Manufacturing Maintenance Technician II Applicants are expected to have a solid experience in handling Job related tasks

Remote

Immunology Thought Leader Liaison SLE Rheumatology Applicants are expected to have a solid experience in handling Job related tasks

Intern Logistics, Order to Cash and Tender Applicants are expected to have a solid experience in handling Order to Cash and Tender related tasks

Head of Biomarker Operations, WCH Applicants are expected to have a solid experience in handling WCH related tasks

Neurology - Key Account Manager (Fixed-Term, 2.5 Years) Applicants are expected to have a solid experience in handling 2.5 Years) related tasks

Senior Associate I, EHS Applicants are expected to have a solid experience in handling EHS related tasks

Director, New Ventures Applicants are expected to have a solid experience in handling New Ventures related tasks

Principal Clinical Data Reviewer/Scientist Applicants are expected to have a solid experience in handling Job related tasks

International Commercial Lead SMA Applicants are expected to have a solid experience in handling Job related tasks

Rare Disease Patient Insights & Advocacy Intern – Nordic & Baltic Region Applicants are expected to have a solid experience in handling Job related tasks

Sr. Manager, Quality Control - Microbiology (Biologics) job opportunity at Biogen Inc..

Saved Jobs

No Job Saved

Other Ai Matches