Roche-posted 1 day ago
$151,600 - $281,500/Yr
Full-time • Senior
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. To strengthen HIT’s capabilities in advanced therapy manufacturing, we are establishing a senior engineering leadership role focused on process engineering, drug product engineering, and cell therapy manufacturing equipment. The Head of Process and Drug Product Engineering will define and lead the strategy for equipment evolution, oversee lifecycle management, and enable innovative, scalable systems that support ongoing clinical manufacturing as well as future commercial production. This role will also represent HIT within the Genentech and Roche global network to align equipment strategy and influence enterprise-level engineering standards for cell therapy manufacturing.

  • Coaching and developing a high-performing team focused on process, drug product, and equipment engineering, fostering technical excellence and engagement.
  • Defining and executing strategies to evolve cell therapy manufacturing and drug product equipment for future capabilities, operational efficiency, and scalability, while supporting new technologies and infrastructure implementations.
  • Ensuring reliable and optimized equipment for clinical manufacturing, leading investigations for deviations, CAPAs, and audits, and supporting timely equipment design, procurement, and qualification for new product introductions and tech transfers.
  • Overseeing risk-based qualification (IQ/OQ/PQ), requalification strategies, and inspection readiness to maintain compliant and efficient equipment operations.
  • Providing direct support for day-to-day clinical manufacturing operations, including process monitoring, troubleshooting, and leading complex quality investigations to ensure patient supply and compliance.
  • Partnering with MSAT, QA, Manufacturing, Supply Chain, and Capital Projects teams to enable compliant integration of equipment, technology upgrades, and infrastructure changes.
  • Acting as a subject matter expert (SME) during audits and inspections, participating in global forums on equipment strategy and harmonization, and influencing enterprise engineering strategies to align with global standards and future needs.
  • Bachelor’s degree in Engineering or other related technical field (Master’s degree is a plus).
  • At least 12 years of engineering, MSAT, or technical operations experience in GMP biopharmaceutical or advanced therapy environments.
  • 5 or more years of leadership experience with responsibility for technical teams in a matrixed or multi-site setting.
  • Deep expertise in cell therapy drug product engineering, process engineering, and lifecycle management of manufacturing equipment.
  • Strong understanding of qualification practices, regulatory requirements, and risk-based validation for GMP equipment.
  • Proven ability to lead investigations, manage change controls, and deliver robust engineering solutions.
  • Experience leading capital projects, tech transfers, and new product introductions for cell and gene therapy.
  • Familiarity with formulation, fill-finish, cryopreservation, and packaging technologies specific to advanced therapies.
  • Demonstrated ability to support ongoing clinical manufacturing operations and maintain inspection readiness.
  • Demonstrated track record of influencing global engineering strategy and representing site functions during audits, inspections, and cross-network initiatives.
  • Discretionary annual bonus based on individual and Company performance.
  • Relocation assistance approved for this posting.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service