Manager Quality Assurance, Microbiology (Drug Product)
Regeneron Pharmaceuticals•Rensselaer, NY
•$92,200 - $206,100•Onsite
About The Position
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager Quality Assurance (QA) Microbiology to join our QA Drug Product team. This operational position is responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of Regeneron’s drug candidates.
Requirements
- BS/BA in Life Sciences or related field; or equivalent combination of education and experience
- Previously people leadership/supervisory experience
Nice To Haves
- Associate Manager QA Microbiology: 6+ years of relevant experience
- Manager QA Microbiology: 7+ years of relevant experience
- Sr. Manager QA Microbiology: 8+ years of relevant experience
Responsibilities
- Manage direct reports, including performance management
- Foster collaborative relationships across Regeneron departments
- Observe microbial/aseptic practices in classified areas; provide feedback and improvement recommendations
- Maintain current expertise in microbiological practices per industry and Regeneron standards
- Analyze Environmental Monitoring (EM) data and guide trending efforts
- Review microbial control documents (SOPs, validation/qualification docs, protocols, technical documents, training materials)
- Provide technical expertise on contamination investigations—root-cause analysis, corrective actions, product impact, and remediation
- Conduct facility walkthroughs for inspection readiness
- Support regulatory inspection logistics and guide responses to findings; communicate updates to senior leadership
- Serve as microbiology subject matter expert for contract manufacturing operation (CMO) quality audits, contributing to audit reports
- Ensure consistency of IOPS Microbial programs across sites through procedures and personnel education
- Develop microbial/aseptic training content, including simulated production scenarios and presentations on processes, expectations, and regulatory requirements
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
