EPM Scientific
Head of Process Development & Manufacturing (Upstream Cell Culture)
EPM Scientific, Boston, Massachusetts, United States, 02298
Head of Process Development & Manufacturing (Upstream Cell Culture)
Job Title:
Head of Process Development & Manufacturing (Upstream Cell Culture)
Department:
Process Development / Manufacturing Science & Technology (MSAT)
Reports To:
Chief Technical Officer
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 bioreactor 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 bioreactor 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.
Base Pay Range Direct message the job poster from EPM Scientific
#J-18808-Ljbffr
Head of Process Development & Manufacturing (Upstream Cell Culture)
Department:
Process Development / Manufacturing Science & Technology (MSAT)
Reports To:
Chief Technical Officer
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 bioreactor 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 bioreactor 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.
Base Pay Range Direct message the job poster from EPM Scientific
#J-18808-Ljbffr