Location: Princeton, NJ or Palo Alto, CA (ONSITE)
Overview of the Role:
We are seeking a Senior Manager, MSAT Drug Substance (Upstream) to support technology transfer, process validation, regulatory submissions (IND/IMPD/BLA/MAA), and inspection readiness for commercial manufacturing. This role will lead upstream technology transfers across internal and external sites, including cell culture scale-up, PPQ execution, CPV and lifecycle monitoring, and will contribute to Module 3 regulatory content. The ideal candidate brings strong expertise in mAb upstream processing, process characterization, control strategy development, and lifecycle management.
Role and Responsibilities:
Provide technical support and leadership for upstream process characterization, validation, and commercial manufacturing support, including process optimization and troubleshooting.
Lead technology transfer activities across internal teams and CDMOs, including scale-up, PPQ execution, and commercial readiness, serving as the primary technical interface with external partners.
Support clinical and commercial manufacturing by ensuring alignment with development timelines, supply plans, and operational readiness.
Assess and manage process risks and lifecycle changes, including risk assessments, deviation investigations, root cause analysis, CAPA, and change control.
Author and review regulatory submissions (IND/IMPD/BLA/MAA Module 3 sections) and provide technical support for health authority interactions.
Oversee PPQ execution and commercial manufacturing support, including person-in-plant activities, ensuring GMP compliance, data integrity, and inspection readiness (PLI/PAI).
Lead change control activities, including impact assessments, and collaborate with Quality and Technical Operations on the development and execution of implementation plans.
Drive continuous improvement initiatives to enhance process robustness, scalability, and operational efficiency.
Travel as needed to support manufacturing, technology transfer, and CDMO oversight.
Perform other duties as assigned.
Educational Background:
Bachelor's degree with 8+ years of relevant experience; Master's degree with 6+ years of relevant experience; PhD with 3+ years of relevant experience.
Professional Experience:
Experience with CHO mammalian cell culture processes, including seed train operations, production bioreactors, media and feed strategies, process scale-up, harvest clarification, technology transfer, and commercial manufacturing support.
Direct experience in process scale-up and technology transfer across scales, systems, and manufacturing sites, including transfer from development through commercial manufacturing; experience with large-scale (>10 kL) stainless steel bioreactors and centrifugation transfer is a plus.
Demonstrated experience performing facility fit assessments, including evaluation of process equipment, critical raw materials, utilities, and manufacturing capabilities to support successful technology transfer and commercialization.
Experience in late-stage process development, characterization and validation is highly valued
Experience authoring IND/IMPD and BLA/MAA Module 3 content, as well as CPV (Continued Process Verification), is highly preferred.
Skills and Competencies:
Proficiency in data analysis and statistical tools (e.g., JMP, DOE, multivariate analysis) to support process understanding and data-driven decision-making.
Strong communication, interpersonal, and project management skills, with the ability to work independently, operate effectively in a matrixed environment, and manage multiple priorities under tight timelines.
Good information management and data organization skills
Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
A track record of working under pressure and delivering high-quality results to tight deadlines.
| Location | Princeton, NJ |