Manager Quality Assurance, Microbiology (Drug Product)

About the Role

This operational position is responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of Regeneron's drug candidates.

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

Environment & Physical Requirements

• Full cleanroom attire 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

Qualifications

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• 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
• Level will be determined based on experience
• Previously people leadership/supervisory experience

Schedule

Monday-Friday, 8am-4:30pm

Location

Rensselaer, New York, United States

Travel

10% domestic & occasionally international