Manager Quality Assurance, Microbiology (Drug Product)

Manager Quality Assurance (QA) Microbiology

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. This operational position is responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of Regeneron's drug candidates.

Location: Rensselaer, New York, United States

Monday-Friday, 8am-4:30pm

Travel percentage: 10% domestic & occasionally international

Discover your role:

• 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

The environment and physical rhythms of the role:

• Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

This role requires:

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• Previously people leadership/supervisory experience

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.