Senior Director, MTS - Aseptic Fill/Finish

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 172,200 - 338,400; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Medical, dental, vision, life and disb

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Director of Manufacturing Technical Services to support aseptic fill/finish manufacturing for clinical and commercial programs.

Located on-site in Rensselaer, NY, the role leads characterization, troubleshooting, tech transfer, and CAPA across a growing team. The position requires 15+ years in biopharma manufacturing with 8+ years in aseptic fill/finish, plus strong regulatory acumen and experience with major packaging lines and automation systems.

Qualifications

• BS or higher in Engineering/Life Sciences required.
• 10+ years biopharma manufacturing experience; 5+ years in aseptic fill/finish.
• Strong regulatory and quality acumen; able to defend technical positions.

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.

Skills

Aseptic fill/finish expertise

Regulatory & quality acumen

Leadership / people management

Education

Bachelor's or higher degree in Engineering, Life Sciences, or related field

Tools

PAS-X

FactoryTalk

PI Vision

GMP instrumentation

Job description

Regeneron Pharmaceuticals, Inc. seeks a Senior Director of Manufacturing Technical Services to support aseptic fill/finish manufacturing for clinical and commercial programs.

Located on-site in Rensselaer, NY, the role leads characterization, troubleshooting, tech transfer, and CAPA across a growing team. The position requires 15+ years in biopharma manufacturing with 8+ years in aseptic fill/finish, plus strong regulatory acumen and experience with major packaging lines and automation systems.