Head of Product Science and Lab Operations (MSAT) (Director)

Responsibilities

• Lead a team of scientists and engineers in the MSAT function to drive process science, technology transfer, and validation strategy for cell therapy manufacturing.
• Develop and align integrated technical strategies for advanced therapies across clinical, process, and manufacturing needs.
• Oversee the MSAT laboratory, guiding experiments and material characterization studies to ensure scientific rigor and regulatory compliance.
• Drive innovation and scalability by implementing platform technologies and automation tools to optimize COGS and speed-to-patient processes.
• Lead complex process troubleshooting and deviation investigations using structured root cause analysis and advanced data analytics.
• Provide technical leadership for allogeneic donor operations, including material qualification and process monitoring.
• Partner with QA, Regulatory, and Manufacturing teams to support lifecycle activities, regulatory filings, and inspections.
• Mentor and develop a high-performing team, fostering leadership skills and GMP compliance.

Requirements

• Bachelor’s degree in Cell Biology, Molecular Biology, Biochemical Engineering, or a related scientific discipline with 12+ years of relevant experience (or Master’s degree with 8+ years).
• 3+ years of direct experience in cell therapy manufacturing.
• 5+ years of experience leading technical teams and managing cross-functional stakeholders.
• Deep expertise in Advanced Therapy Medicinal Products (ATMPs), including autologous and allogeneic workflows.
• Proven track record supporting regulatory submissions (e.g., IND, BLA) and health authority inspections.
• Proficiency with process monitoring and analytics tools such as JMP, Spotfire, or PI Historian.

About the Company

Genentech, a member of the Roche group, is a pioneer in the biotechnology industry. We are dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our Hillsboro Innovative Therapies (HIT) campus serves as a critical hub for emerging cell and gene therapy manufacturing.