Head of Biologics MSAT

Head of Biologics MSAT

• Can be based in Philadephlia 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:

• Ph.D. or M.S. in Biochemical Engineering, Biotechnology, or related field; Ph.D. preferred.
• 15+ years of experience in biologics manufacturing, with at least 7 years in a leadership role within MSAT or Technical Operations.
• Deep understanding of scale-up, upstream & downstream biologics processes, tech transfers, and regulatory requirements.
• Experience with CMO/CRO management and global manufacturing networks.
• Demonstrated success in leading cross-functional teams and managing complex projects.
• Consistently acting and leading with personal accountability for the quality and compliance of the MSAT team and beyond.
• Extensive experience in structured technical troubleshooting, RCA and CAPA effectiveness
• Excellent communication, leadership, and strategic thinking skills.

Preferred Experience:

• Experience with advanced biologics modalities (e.g., bispecifics, fusion proteins, ADCs, monoclonal antibodies).
• Familiarity with digital tools for process monitoring and data analytics.
• Prior experience in a fast-paced biotech or a global pharmaceutical environment.