Head of Process Development MSAT

Job Description

Head of Process Development MSAT

Can be based in Philadelphia or Boston

Position Summary :

The head of Biologics MSAT will lead the strategic and operational oversight of the Manufacturing Science and Technology function for biologics DS and / or DP manufacturing. This role is responsible for ensuring robust technology transfer, process validation, lifecycle management, and continuous improvement of biologics manufacturing processes across internal and external manufacturing global sites. The ideal candidate will bring deep technical expertise in biologics (e.g., monoclonal antibodies, ADCs, dAbs, fusion proteins), strong leadership capabilities, and a proven track record of cross-functional collaboration.

Key Responsibilities :

• Lead and develop a high-performing MSAT team supporting clinical and commercial biologics manufacturing.
• Oversee technology transfer of biologics processes from development to manufacturing, ensuring scalability, robustness, and compliance.
• Drive global process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH).
• Provide technical leadership for troubleshooting, deviation investigations, and CAPA implementation.
• Partner with Quality, Regulatory, Development, and Manufacturing to ensure seamless product lifecycle management.
• Lead initiatives for process optimization, cost reduction, and implementation of new technologies (e.g., PAT, automation, single-use systems).
• Consistently acting and leading with personal accountability for the quality and compliance of the MSAT team and beyond.
• Serve as a subject matter expert during regulatory inspections and audits.
• Develop and manage MSAT budgets, resource planning, and strategic initiatives.
• Foster a culture of innovation, scientific excellence, and continuous improvement.

Qualifications :

Experience :

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