Quality Control Analyst - Potency Assays

Roche • Hillsboro, OR

11d • Onsite

About 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. The Opportunity: As a Potency Quality Control Analyst, your main function will be to ensure data integrity and compliance with established guidelines through various analytical tasks. Additionally, you will: 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 standards

Requirements

• You possess a Bachelor’s degree and at least 2 years of relevant laboratory experience in Chemistry, Biochemistry, Molecular Biology or a relevant scientific discipline; Master’s degree is plus
• You are proficient in running and validating cell-based and biochemical methods, including cell viability, cell killing, barrier function and immunoassays (ELISA)
• You possess demonstrated skills in applying scientific theories and techniques to analytical or biological testing
• You have a strong aptitude for interpreting and implementing Quality standards
• You are an energetic and driven self-starter, a team player with excellent verbal and written communication skills, able to effectively absorb and present information
• You possess strong problem-solving capabilities
• 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

Nice To Haves

• 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)

Responsibilities

• 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 standards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees