Principal Technical Manager
About The Position
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. The Analytical Science & Technology (AS&T) team is the backbone of our Quality Control operations, ensuring the integrity and compliance of our laboratory systems and data. As a member of this team, you will partner with laboratory experts, procurement specialists, and global stakeholders to oversee critical programs that enable the delivery of high-quality cell and gene therapies to patients. Your work will directly impact laboratory operational excellence and support our commitment to rigorous quality standards across all manufacturing sites. As a Principal Technical Manager, you will lead the oversight of Raw Materials and Equipment Qualification programs within our Quality Control organization, serving as a key liaison between laboratory operations, procurement, and global governance functions. Your strategic guidance will ensure that all QC programs maintain compliance with current GxP requirements while supporting continuous operational improvement. Responsibilities include: Establish and manage comprehensive Raw Material testing programs at our facility, partnering with procurement teams and Contract Laboratory Organizations to ensure consistent material availability and quality for production Create, execute, and oversee detailed test plans for laboratory equipment qualification, ensuring all systems meet validated performance standards Represent Quality Control in global and local governance committees and cross-functional project meetings, advocating for Raw Material and Equipment Qualification priorities Collaborate with subject matter experts and stakeholders across manufacturing, quality, and procurement to translate complex technical requirements into compliant system configurations Identify, investigate, and resolve deviations while maintaining adherence to all Quality policies and regulatory standards Drive continuous improvement initiatives across the QC department through data-driven insights and process optimization Mentor and support laboratory teams in the execution of qualification protocols and maintenance of validated system lifecycles
Requirements
- Bachelor's degree in life sciences or a related discipline, with a minimum of 5 years of analytical laboratory experience in a regulated industry (pharmaceutical, biotech, or cell and gene therapy)
- Strong working knowledge of GMP and GLP requirements, with demonstrated expertise in data integrity, documentation, and compliance within a regulated manufacturing environment
- Proven ability to manage stakeholder relationships across a matrixed organization, including collaborating effectively with procurement, Contract Laboratories, global quality teams, and local operations
- Exceptional written and verbal communication skills with the ability to translate complex technical documentation into clear requirements and identify project risks for senior management escalation
- Demonstrated experience managing Raw Material testing programs—both internally and with external Contracted Laboratories—and/or qualifying laboratory equipment and systems in a validated system lifecycle
Nice To Haves
- Direct experience with Cell and Gene Therapy manufacturing or testing processes
- Experience managing GxP Raw Material testing both internally and with Contracted Laboratories
- Experience with the Qualification of laboratory equipment and systems
- Experience with testing protocols and execution within a validated system lifecycle
Responsibilities
- Establish and manage comprehensive Raw Material testing programs at our facility, partnering with procurement teams and Contract Laboratory Organizations to ensure consistent material availability and quality for production
- Create, execute, and oversee detailed test plans for laboratory equipment qualification, ensuring all systems meet validated performance standards
- Represent Quality Control in global and local governance committees and cross-functional project meetings, advocating for Raw Material and Equipment Qualification priorities
- Collaborate with subject matter experts and stakeholders across manufacturing, quality, and procurement to translate complex technical requirements into compliant system configurations
- Identify, investigate, and resolve deviations while maintaining adherence to all Quality policies and regulatory standards
- Drive continuous improvement initiatives across the QC department through data-driven insights and process optimization
- Mentor and support laboratory teams in the execution of qualification protocols and maintenance of validated system lifecycles
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Relocation benefits are not approved for this posting.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
