Sr. Manager, Quality Control Microbiology (Biologics)
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 120000 - 161000
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
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 Youll 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
Bachelors degree in Microbiology Biology or related field (Masters 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 $10000 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 onto 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.
Required Experience:
Manager
Key Skills
- Laboratory Experience
- Quality Assurance
- Construction Experience
- FDA Regulations
- ISO 9001
- Assays
- Quality Systems
- Quality Control
- Quality Management
- cGMP
- QA/QC
- HACCP
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
