Senior Director Manufacturing Technical Services
Regeneron
August 20, 2026
On-site
East Greenbush, NY
Operations
Responsibilities:
- Lead technical characterization, cycle development, and troubleshooting for aseptic fill/finish equipment (filling systems, isolators, stoppering, capping, visual inspection, device assembly, labeling, packaging).
- Direct tech transfer activities (clinical/new product introductions, site-to-site transfers, scale-up/scale-down).
- Own the visual inspection program (manual inspector qualification/AQL and automated inspection/AVI; defect library development; camera/algorithm optimization).
- Oversee alarm management and process monitoring strategy (PAT, continuous monitoring, alarm rationalization).
- Serve as key technical resource during regulatory inspections/health authority interactions; author and defend technical justifications.
- Own CAPA and root cause investigations for deviations/complaints tied to fill/finish equipment or process.
- Build and develop a multi-faceted technical team; grow MTS function maturity.
- Communicate technical/equipment risk to senior leadership and translate into executable steps for manufacturing operations.
Qualifications:
- Senior Director: Bachelor’s or advanced degree in Engineering, Life Sciences, or related field; 15+ years biopharmaceutical manufacturing experience including 8+ years in aseptic fill/finish (or equivalent combination/experience).
- Deep expertise in aseptic fill/finish equipment characterization and troubleshooting (commercial and clinical lines).
- Strong regulatory and quality acumen; ability to support inspections and defend technical positions.
- Preferred: 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).
Application instructions:
- Apply now.
- Lead technical characterization, cycle development, and troubleshooting for aseptic fill/finish equipment (filling systems, isolators, stoppering, capping, visual inspection, device assembly, labeling, packaging).
- Direct tech transfer activities (clinical/new product introductions, site-to-site transfers, scale-up/scale-down).
- Own the visual inspection program (manual inspector qualification/AQL and automated inspection/AVI; defect library development; camera/algorithm optimization).
- Oversee alarm management and process monitoring strategy (PAT, continuous monitoring, alarm rationalization).
- Serve as key technical resource during regulatory inspections/health authority interactions; author and defend technical justifications.
- Own CAPA and root cause investigations for deviations/complaints tied to fill/finish equipment or process.
- Build and develop a multi-faceted technical team; grow MTS function maturity.
- Communicate technical/equipment risk to senior leadership and translate into executable steps for manufacturing operations.
Qualifications:
- Senior Director: Bachelor’s or advanced degree in Engineering, Life Sciences, or related field; 15+ years biopharmaceutical manufacturing experience including 8+ years in aseptic fill/finish (or equivalent combination/experience).
- Deep expertise in aseptic fill/finish equipment characterization and troubleshooting (commercial and clinical lines).
- Strong regulatory and quality acumen; ability to support inspections and defend technical positions.
- Preferred: 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).
Application instructions:
- Apply now.