Jobs · Management · New York

Senior Director Manufacturing Technical Services

BioSpace · East Greenbush, NY · Today
Management$172k–$338k/yrFull-time

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.

Location: Rensselaer, NY
Work model/flexibility: On-site
Schedule: Monday–Friday, 8am–4:30pm

About the role

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

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

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 of 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 of 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 (VarioSys, CombiSys), Seidenader Inspection, Harro Höfliger assembly, or Körber (Dividella/Pester) packaging preferred
  • Automation/data historian familiarity (PAS-X, FactoryTalk, PI Vision) preferred

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
  • Family support benefits

Pay

Salary Range (annually): $172,200.00 – $338,400.00

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