Senior Director Manufacturing Technical Services
About The Position
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.
Requirements
- 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
Nice To Haves
- Platform experience with Bausch+Ströbel (VarioSys, CombiSys), Seidenader Inspection, Harro Hofliger assembly, or Körber (Dividella/Pester) packaging preferred
- Automation/data historian familiarity (PAS-X, FactoryTalk, PI Vision) preferred
Responsibilities
- 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
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
