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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

Requirements

• Previously people leadership/supervisory experience
• 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
• 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.

Location

• Rensselaer, New York, United States

Work Type

• Onsite
• Monday-Friday, 8am-4:30pm

Experience Level

• 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

Education Level

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

Salary/Compensations

• $92,200.00 - $206,100.00

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

About the Company

• Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
• Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.
• Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
• Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Equal Opportunity

• 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.