Senior Director Manufacturing Technical Services

About the Role

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.

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 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

Preferred Qualifications

• 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

Schedule

Monday–Friday, 8:00am–4:30pm, on-site at the Rensselaer, NY location.

Pay

Annual salary range: $172,200.00 – $338,400.00