Manager Quality Assurance, Microbiology (Drug Product)

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.

When & where:

• 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
  • 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

 

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$92,200.00 - $206,100.00