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

Genentech’s Hillsboro Oregon campus—Hillsboro Innovative Therapies (HIT)—serves as a critical hub for emerging cell & gene therapy manufacturing. Housed within a modern 75-acre facility just outside Portland, HIT is at the forefront of advancing cell and gene therapy medicines through accelerated clinical and commercial manufacturing capabilities, aligning with Genentech’s mission to bring transformative therapies to patients.

As part of Genentech’s Cell and Gene Therapy community, this role offers the opportunity to shape and scale advanced therapy platforms through cross-site collaboration, data-driven innovation, and continuous improvement.  This leader will play a pivotal role in defining and executing the MSAT strategy for cell therapy, guiding decisions, influencing global technology platforms, and representing HIT in strategic Roche network initiatives.

The Opportunity:

As the Head of Product Science and Lab Operations, you will lead a team of scientists and engineers within the Manufacturing Science and Technology (MSAT) function, focused on process science, technology transfer, and process validation strategy for cell therapy manufacturing. This team plays a pivotal role in enabling right-first-time manufacturing through data-driven process design, lifecycle validation, deviation investigation, and continuous improvement. In this role, you will serve as the strategic leader for each of these areas from development through commercial manufacturing and will also be responsible for the MSAT laboratory.

In addition to site responsibilities, you will serve as a network-level thought partner, representing HIT in enterprise planning forums, platform strategy discussions, and cross-functional governance bodies.  You will be accountable for establishing scalable and future-ready MSAT capabilities that enable Genentech’s growing cell therapy portfolio across the development and commercial lifecycle.  Key responsibilities include:

• Developing and Aligning Strategies: Creating integrated technical strategies for advanced therapies across clinical, process, manufacturing, and analytic needs, while aligning with Genentech’s cell therapy platforms and Roche network goals.

• Driving Innovation and Scalability: Identifying and implementing platform technologies, automation tools, and global synergies to reduce cycle times, optimize COGS, and improve scalability, traceability, and speed-to-patient processes.

• Overseeing Process Validation and Technology Transfer: Leading end-to-end process validation strategies, executing process implementation plans, and championing global standards for technology transfer and manufacturing excellence.

• MSAT Laboratory Leadership: Oversee and guide laboratory experiments and material characterization studies, ensuring scientific rigor, regulatory compliance, and alignment with clinical and commercial manufacturing needs. Provide technical direction to design and execute studies that generate critical process knowledge and support technology transfer.

• Allogeneic Donor Program Support: Provide technical leadership for allogeneic donor operations, including laboratory activities, donor material qualification, and process monitoring. Partner with clinical, supply chain, and manufacturing teams to ensure a reliable and compliant supply of qualified donors to meet program and production needs.

• Investigations and Troubleshooting: Lead complex process troubleshooting and deviation investigations using structured root cause analysis methodologies and advanced data analytics. Partner cross-functionally to identify, document, and implement corrective and preventive actions that drive robust, reliable, and compliant manufacturing operations.

• Collaborating Across Stakeholders: Partnering with QA, Regulatory, Manufacturing, and other teams to support lifecycle activities, regulatory filings, inspections, and global technical alignment.

• Mentoring and Developing Talent: Building, coaching, and engaging a high-performing team while fostering scientific rigor, leadership skills, GMP compliance, and innovation.

• Representing Genentech Globally: Acting as a technical leader in regulatory interactions, industry consortia, and governance boards to influence global regulatory and scientific advancements.
   

Who You Are:

• You possess a Bachelor’s degree in Cell Biology, Molecular Biology, Biochemical Engineering, or a related scientific discipline along with 12 years of direct relevant experience (or Master’s degree with 8+ years of directly relevant experience)

• You have at least 3 years of experience in cell therapy manufacturing, with 5+ years leading technical teams and managing cross-functional stakeholders

• You possess a deep understanding of cell therapy platforms, process control, and regulatory expectations, including process validation, technology transfer, and lifecycle management

• You have a proven track record of supporting regulatory submissions (e.g., IND, BLA) and health authority inspections

• You possess expertise in advanced therapy medicinal products (ATMPs), including autologous and allogeneic workflows

• You have experience with process monitoring and analytics tools (e.g., JMP, Spotfire, PI Historian) and MSAT lab operations (e.g., scale-down studies, closed-system modeling)

• You have experience leading data-driven scientific investigations and driving continuous improvement, digital integration, or innovation in regulated environments

• You have demonstrated success influencing technical strategy across sites or global teams

Relocation is approved for this posting. 

This is an on-site position; no remote options are offered at this time. 

The expected salary range for this position based on the primary location of Oregon is $151,600 - $281,500.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed in this link.

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