Head of Analytical Development and Testing for Cell and Gene Therapeutics

This position is part of our Pharma Technical Cell and Gene Therapy (PTC) team, based in Hillsboro, Oregon, which is dedicated to the development of cell and gene therapeutics (CGT). As the leader of the Analytical Development and Quality Control team, you will play a pivotal role in designing, developing, and implementing analytical methods critical to CGT clinical and commercial production. This role offers the opportunity to work collaboratively with technical development teams and other PTC functions to ensure product quality and manufacturing consistency, contributing to our mission of bringing innovative therapies to patients swiftly and effectively.

The Opportunity:

As the Head of Analytical Development and Testing (Director level), you will lead a dedicated cross-functional team responsible for operational, analytical development, and quality control (QC) activities supporting the clinical development of cell and gene therapeutics. You will drive the design, development, and implementation of analytical methods and processes to ensure production consistency and product quality. Additionally, you will:

• Lead, build, and manage an agile Analytical Development and Quality Control (ADQC) team to support PTC's mission

• Design and implement analytical methods in partnership with internal and external stakeholders to support GMP production

• Develop and enforce QC SOPs, specifications, and testing methods compliant with cGMP regulations

• Provide technical leadership for rapid resolution of operational and technical issues, including root cause analysis and corrective/preventive actions (CAPA)

• Coordinate and support regulatory inspections, partner audits, and third-party laboratory approvals

• Promote continuous improvement and lean principles throughout the organization by advocating for innovation and learning

Who You Are:

• You possess a Master's or Bachelor's degree in biology, biochemistry, analytical chemistry, chemical engineering or a related field with at least 10 years of relevant industry experience; or a Ph.D. with at least 8 years of relevant industry experience

• You have comprehensive know-how in method development/qualification/validation and quality control to support CGT development and manufacturing

• You have a demonstrated track record of progressive leadership roles, showcasing your ability to lead, build, and inspire high-performing teams

• You are courageous and decisive, willing to take risks and make difficult decisions under ambiguity to achieve exceptional business results and drive high productivity

• You have an in-depth knowledge of GMP and extensive experience in Quality Control

• You have a demonstrated ability in analytical method development, qualification/validation, and implementation

• You are highly analytical with strong troubleshooting skills and problem-solving capabilities, experienced in working effectively in a global network and a matrixed environment

• You are able to work in an office and laboratory environment

• You are able to travel up to 20% to other sites as required

The expected salary range for this position based in Oregon is $126,000 (min) - $180,000 (mid) - $234,000 (max). 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 at the link provided below.

Benefits

Relocation benefits are approved for this posting.

This is an on-site role, no remote or hybrid options are available.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.