Head of Process and Drug Product Engineering (MSAT) (Director)

Head Of Process And Drug Product Engineering

Genentech's Hillsboro Oregon campusHillsboro Innovative Therapies (HIT)serves as a critical hub for emerging cell and 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.

As the Head of Process and Drug Product Engineering, you will provide strategic and operational leadership for process engineering, drug product engineering, and the lifecycle management of cell therapy manufacturing equipment. This includes responsibility for equipment design, qualification, technology transfer support, and long-term strategy to evolve and continuously improve cell therapy processing technologies. This role is both strategic and hands-on, requiring deep technical expertise, strong leadership capabilities, and the ability to influence network-wide engineering strategies.

In this key leadership position, you will build a high-performing team that supports day-to-day clinical manufacturing operations, drug product systems, formulation and fill-finish technologies, and end-to-end equipment used in cell therapy manufacturing. Key responsibilities include :

• Leading and Developing Engineering Teams : Coaching and developing a high-performing team focused on process, drug product, and equipment engineering, fostering technical excellence and engagement.
• Driving Equipment Strategy and Innovation : 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.
• Providing Technical Leadership : 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.
• Owning Equipment Qualification Lifecycle : Overseeing risk-based qualification (IQ / OQ / PQ), requalification strategies, and inspection readiness to maintain compliant and efficient equipment operations.
• Supporting Ongoing Clinical Manufacturing : 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.
• Collaborating Cross-Functionally : Partnering with MSAT, QA, Manufacturing, Supply Chain, and Capital Projects teams to enable compliant integration of equipment, technology upgrades, and infrastructure changes.
• Representing MSAT Internally and Externally : 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.

You possess a Bachelor's degree in Engineering or other related technical field (Master's degree is a plus). You have at least 12 years of engineering, MSAT, or technical operations experience in GMP biopharmaceutical or advanced therapy environments. You have 5 or more years of leadership experience with responsibility for technical teams in a matrixed or multi-site setting. You possess a deep expertise in cell therapy drug product engineering, process engineering, and lifecycle management of manufacturing equipment. You have a strong understanding of qualification practices, regulatory requirements, and risk-based validation for GMP equipment. You have a proven ability to lead investigations, manage change controls, and deliver robust engineering solutions. You have experience leading capital projects, tech transfers, and new product introductions for cell and gene therapy. You have a familiarity with formulation, fill-finish, cryopreservation, and packaging technologies specific to advanced therapies. You possess a demonstrated ability to support ongoing clinical manufacturing operations and maintain inspection readiness. You have a demonstrated track record of influencing global engineering strategy and representing site functions during audits, inspections, and cross-network initiatives.

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.