Head of Process Development Biologics

Job Title: Head of Process Development & Manufacturing (Upstream Cell Culture)

Location: Boston, MA (Hybrid)

Department: Process Development / Manufacturing Science & Technology (MSAT)

Reports To: Chief Technical Officer or equivalent

Position Summary

We are seeking a visionary and technically accomplished Vice President to lead our Upstream Process Development and MSAT functions. This executive role is pivotal in shaping and executing the strategy for late-stage development and commercialization of our biologic portfolio. The ideal candidate will bring extensive experience in upstream bio processing, strategic leadership, and a history of successful tech transfer and commercial manufacturing oversight.

Key Responsibilities

• Define and lead the strategic direction for upstream process development and MSAT across the biologic pipeline.
• Oversee development and scale-up of cell culture processes, including cell line selection, media optimization, and bio reactor operations.
• Lead MSAT initiatives including process characterization, validation (PPQ), CPV, and life cycle management.
• Direct technology transfer to internal and external GMP manufacturing sites, ensuring robust, scalable, and compliant processes.
• Serve as a key technical leader in regulatory submissions (IND, BLA) and interactions with global health authorities.
• Collaborate with executive leadership and cross-functional teams including QA, QC, Regulatory Affairs, Clinical Development, and CDMOs.
• Build and mentor a world-class team of scientists and engineers, fostering innovation and operational excellence.
• Drive continuous improvement and adoption of cutting-edge technologies to enhance process performance and product quality.
• Manage departmental budgets, long-term planning, and resource allocation.

Qualifications

• Ph.D. in Biochemistry, Chemical Engineering, Biotechnology, or related discipline.
• Minimum 20 years of experience in biologic process development, with at least 10 years in executive or senior leadership roles.
• Deep expertise in upstream processing, including mammalian cell culture and large-scale bio-reactor operations.
• Comprehensive understanding of MSAT principles, GMP regulations, and commercial manufacturing.
• Proven track record of successful tech transfer, scale-up, and global manufacturing support.
• Experience leading regulatory strategy and contributing to IND/BLA filings.
• Exceptional leadership, strategic thinking, and cross-functional collaboration skills.

Preferred Qualifications

• Experience managing global manufacturing networks and CDMO partnerships.
• Prior leadership in commercial product launches and regulatory inspections.
• Expertise in QbD, statistical process control, and digital manufacturing technologies.