Principal Technical Manager

Reposted Yesterday
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Hillsboro, OR, USA
In-Office
102K-190K Annually
Senior level
Healthtech • Biotech
The Role
Responsible for overseeing Raw Materials and Equipment Qualification programs in Quality Control, ensuring compliance with GxP standards and continuous operational improvement.
Summary Generated by Built In

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.

The Opportunity

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

Who You Are

  • 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

Preferred Experience:

  • 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

The expected salary range for this position based on the primary location of Oregon is $102,200 - $189,800.  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.

Relocation benefits are not approved for this posting.
This is an on-site position; no remote options are offered at this time. 

#LI-CA1

#ptcareers

#cellandgenetherapycareers#

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Skills Required

  • Bachelor's degree in life sciences or related discipline
  • Minimum of 5 years of analytical laboratory experience in a regulated industry
  • Strong knowledge of GMP and GLP requirements
  • Ability to manage stakeholder relationships across a matrixed organization
  • Exceptional written and verbal communication skills
  • Experience managing Raw Material testing programs and/or qualifying laboratory equipment and systems

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.

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