Manager Quality Assurance, Microbiology (Drug Product)

Location: Rensselaer, New York, United States

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

Work Environment

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

Schedule

Monday–Friday, 8:00 AM–4:30 PM

Travel: 10% domestic and occasionally international

Requirements

• 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
• Previous people leadership/supervisory experience

Pay

Salary Range (annually): $92,200.00 – $206,100.00

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• 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