QA Microbiology Specialist (Advanced Therapies

QA Microbiology Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a QA Microbiology Specialist position within our Advanced Therapies Quality Assurance team. This position provides technical expertise and quality oversight for microbiology, contamination control, and microbial quality programs supporting Advanced Therapies operations. This role supports developing and overseeing microbiological control strategies, supports regulatory and compliance activities, supports driving platform-level microbial testing approaches, and serves as a key quality partner for process development, technology transfer, and external manufacturing operations.

Location:

East Greenbush, New York, United States

Work schedule:

Monday-Friday, 8am-4:30pm

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

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.

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.

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.

• 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.

This role requires:

• 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.