Senior Director Manufacturing Technical Services

Senior Director, Manufacturing Technical Services (MTS)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director, Manufacturing Technical Services (MTS) to join our team, supporting our fill/finish clinical and commercial drug product manufacturing operations. In this role, you will provide technical leadership across equipment characterization, cycle development, tech transfer, and troubleshooting for our aseptic fill/finish value stream, while collaborating with Quality, Engineering, Automation, and Validation to keep our fill/finish equipment and processes in a state of control.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location:

Rensselaer NY

Work model/flexibility:
On-site

Monday
- Friday, 8am-4:30pm

Discover your role:

• Leads technical characterization, cycle development, and troubleshooting for aseptic fill/finish equipment, including filling systems, isolators, stoppering, capping, visual inspection, device assembly, labeling, and packaging
• Directs tech transfer activities, including clinical and new product introductions, site-to-site transfers, and scale-up/scale-down
• Owns the visual inspection program, spanning manual inspector qualification/AQL and automated inspection (AVI) systems, including defect library development and camera/algorithm optimization
• Oversees alarm management and process monitoring strategy, including PAT, continuous monitoring, and alarm rationalization
• Serves as a key technical resource during regulatory inspections and health authority interactions, authoring and defending technical justifications
• Owns CAPA and root cause investigations for deviations and complaints tied to fill/finish equipment or process
• Builds and develops a multi-faceted technical team, growing the maturity of the MTS function over time
• Communicates technical and equipment risk clearly to senior leadership, translating it into executable steps for manufacturing operations

This role requires:

• Director Level: Bachelor's or advanced degree in Engineering, Life Sciences, or a related technical field and 10+ years of biopharmaceutical manufacturing experience, including 5+ years in aseptic fill/finish or equivalent combination or education and experience
• Senior Director Level: Bachelor's or advanced degree in Engineering, Life Sciences, or a related technical field and 15+ years of biopharmaceutical manufacturing experience, including 8+ years in aseptic fill/finish or equivalent combination or education and experience
• Deep expertise in aseptic fill/finish equipment characterization and troubleshooting for commercial and clinical manufacturing lines
• Strong regulatory and quality acumen, with the ability to support inspections and defend technical positions to health authorities
• Platform experience with Bausch+Ströbel (Vario Sys, Combi Sys), Seidenader Inspection, Harro Hofliger assembly, or Körber (Dividella/Pester) packaging preferred
• Automation/data historian familiarity (PAS-X, Factory Talk, PI Vision) preferred

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.