Director, QA Microbiology (Drug Product Manufacturing)
RegeneronMesa, Arizona, United States
Posted April 9, 2026
147800 - 286900 USD
Full Time
About the Company
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
Job Description
We are currently looking to fill a Director QA Microbiology position to drive the continuous improvement of contamination control and sterility assurance programs at Regeneron’s Drug Product Fill/Finish site. This role will strengthen practices and procedures that safeguard product sterility, assess and implement new technologies to enhance patient safety, and maintain a robust facility bioburden and sterility strategy.
Requirements
- Comprehensive knowledge of microbiological expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations, and guidelines, particularly CMC and GMP.
- Experience building up a quality culture and quality management capabilities.
- Comprehensive knowledge and experience in CMC section content for investigational and marketed product submissions (IND, BLA, CBE, PAS) for FDA and equivalent submissions for Europe.
- Ability to articulate and execute concepts for developing and ensuring the highest quality throughout the network (internal and external).
- Intellect for quality risk identification, mitigation, and management.
- Strong leadership and communication skills —written and oral.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)