THE POSITION

This position is part of a consolidated Analytical Development and Quality Control (ADQC) team within Genentech’s cutting edge Pharma Technical Cell and Gene Therapy (PTC) organization. PTC is dedicated to advancing cell and gene therapies aimed at treating or curing various diseases. In this position, you’ll conduct quality control (QC) activities to support the clinical progress of cell and gene therapies.
As a member of Genentech’s Hillsboro Innovative Therapies (HIT) QC team, you will perform analyses of cellular attributes and secreted molecules from in-process samples and finished products, including cell-based functional, biochemical and chemical tests. You will gather data for test procedure documentation, calibrate and maintain laboratory equipment, and contribute to drafting procedures, summaries, reports and investigations. Additionally, you will support activities for method improvements and method lifecycle.

PREFERRED EXPERIENCE:

• You possess experience working in the pharmaceutical or biopharmaceutical industry, specifically in the contexts of QC Cell therapy
• You have a solid understanding of cGMPs or similar regulations (strongly preferred)

PHYSICAL REQUIREMENTS:

• You are able to work in both office and laboratory settings, with extended periods working at benches and frequent lifting (up to 25 lbs), bending, reaching, and twisting
• Use of stepladders and pushcarts
• Must pass visual screening

• Conduct analytical testing, qualify and validate methods, and implement new potency assessment procedures to support GMP production
• Draft and review documentation for equipment qualification, method implementation, and procedures
• Collaborate with Genentech’s Technical Development Teams (TDTs), PTC functions, Pharma Technical Development (PTD), and global teams to achieve clinical proof of concept and prepare for commercial production
• Calibrate and maintain laboratory and analytical equipment to ensure accurate and consistent results
• Support the development of new potency testing or analysis methods and protocols for routine and non-routine analyses
• Technically review data, checking against defined acceptance criteria, and identify technical issues, deviations, and discrepancies
• Support internal and external audits and regulatory inspections, maintaining compliance and quality standard