QA Microbiology Specialist (Advanced Therapies)

Microbiology & Contamination Control Support

Provide technical support and oversight for microbiological quality systems and contamination control programs, including:

• Support the development, implementation, and maintenance of contamination control strategies aligned with regulatory requirements and industry best practices.
• Review and assess environmental monitoring programs and associated data trends.
• Provide oversight and technical assessment of bioburden, endotoxin, and other microbiological testing activities.
• Conduct microbiological risk assessments and support implementation of mitigation actions.
• Technical support for regulatory submissions, inspections, and responses to Regulatory Information Requests

Microbiology Program Development & Continuous Improvement

Contribute to the advancement of microbiology programs and initiatives by:

• Supporting the development and standardization of microbiological practices across Advanced Therapies programs.
• Participating in cross-functional discussions to align microbiological requirements and contamination control expectations.
• Identifying opportunities for process improvements and enhancements to microbial quality programs.
• Monitoring industry and regulatory trends to recommend enhancements to microbiological programs.

Technology Transfer, Sampling Plans & Process Support

Provide microbiology expertise to support manufacturing and product lifecycle activities, including:

• Review and approve microbiology-related sampling plans.
• Review Process Transmittal Requirement documents and technical transfer documentation.
• Support development and optimization of in-process, raw material, buffer, and product testing strategies.
• Partner with Manufacturing, Process Development, and Quality teams during technology transfer activities.
• Evaluate microbiological considerations associated with process changes and new product introductions.

Quality Event Review & Investigation Support

Support microbiology-related quality systems and issue resolution activities, including:

• Review batch, release, and in-process testing deviations for microbiological impact.
• Assess microbiology-related deviations, nonconformances, and quality events.
• Participate in investigations, root cause analyses, and development of corrective and preventive actions (CAPAs).
• Support Quality Council discussions and other quality governance activities as needed.
• Assess microbiological impact of supplier changes, material changes, and manufacturing modifications.
• Provide technical recommendations to support product disposition and quality decisions.

Cross-Functional Partnership & Technical Expertise

• Serve as a microbiology subject matter expert within Quality and Manufacturing organizations.
• Provide technical guidance on microbiological testing, contamination control, and microbial risk management.
• Collaborate with internal and external stakeholders to support microbiological compliance and quality objectives.
• Share knowledge and mentor colleagues on microbiology-related processes and best practices.
• Promote a culture of quality, compliance, and continuous improvement.

• Bachelor’s degree in Microbiology, Biological Sciences, Biotechnology, Pharmacy, or a related scientific discipline, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
• Associate Specialist – 0-2 years
• Specialist - 2+ years
• Senior Specialist - 5+ years
• Level will be determined based on experience
• Experience in pharmaceutical, biotechnology, cell and gene therapy, or advanced therapies manufacturing environments.
• Strong knowledge of Environmental monitoring programs, Contamination control strategies, Bioburden and endotoxin testing, Aseptic processing principles, Microbiological quality systems.
• Experience supporting investigations, deviations, CAPAs, and risk assessments.
• Familiarity with regulatory expectations and inspection readiness activities.
• Strong technical writing, communication, and cross-functional collaboration skills.
• Ability to independently assess microbiological risks and provide scientifically sound recommendations.

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.