Head of Analytical Development and Testing for Cell and Gene Therapeutics

$126,000 - $234,000/Yr

Genentech - Hillsboro, OR

Full-time - Senior

Hillsboro, OR

Professional, Scientific, and Technical Services

About the position

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.

Responsibilities

• 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

Requirements

• 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
• Comprehensive know-how in method development/qualification/validation and quality control to support CGT development and manufacturing
• Demonstrated track record of progressive leadership roles, showcasing ability to lead, build, and inspire high-performing teams
• Courageous and decisive, willing to take risks and make difficult decisions under ambiguity to achieve exceptional business results and drive high productivity
• In-depth knowledge of GMP and extensive experience in Quality Control
• Demonstrated ability in analytical method development, qualification/validation, and implementation
• Highly analytical with strong troubleshooting skills and problem-solving capabilities, experienced in working effectively in a global network and a matrixed environment
• Ability to work in an office and laboratory environment
• Ability to travel up to 20% to other sites as required

Benefits

• Relocation benefits are approved for this posting.
• Discretionary annual bonus may be available based on individual and Company performance.