Genentech-posted 1 day ago
$151,600 - $281,500/Yr
Full-time
Hillsboro, OR

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.

  • 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.
  • Allogeneic Donor Program Support: Provide technical leadership for allogeneic donor operations, including laboratory activities, donor material qualification, and process monitoring.
  • Investigations and Troubleshooting: Lead complex process troubleshooting and deviation investigations using structured root cause analysis methodologies and advanced data analytics.
  • 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.
  • PhD in Cell Biology, Molecular Biology, Biochemical Engineering, or a related scientific discipline with 7 years of direct relevant experience, or a Master’s degree with 10+ years of directly relevant experience.
  • At least 12 years of experience in biopharmaceutical or cell therapy manufacturing, with 5+ years leading technical teams and managing cross-functional stakeholders.
  • Deep understanding of cell therapy platforms, process control, and regulatory expectations, including process validation, technology transfer, and lifecycle management.
  • Proven track record of supporting regulatory submissions (e.g., IND, BLA) and health authority inspections.
  • Expertise in advanced therapy medicinal products (ATMPs), including autologous and allogeneic workflows.
  • 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).
  • Experience leading data-driven scientific investigations and driving continuous improvement, digital integration, or innovation in regulated environments.
  • Demonstrated success influencing technical strategy across sites or global teams.
  • Discretionary annual bonus based on individual and Company performance.
  • Relocation assistance approved for this posting.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service