Quality Control Analyst

The Position

This position is part of a consolidated analytical development team within the new 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 analytical development (AD) and quality control (QC) activities to support the clinical progress of individualized medicines and cell therapies.

As a member of the Analytical Development and Testing (ADT) team, you will perform analyses of raw materials, in-process samples, and finished products, including biochemical and chemical tests. You will gather data for test procedure documentation, calibrate and maintain laboratory equipment, and contribute to drafting investigations, summaries, and reports. Additionally, you will develop testing and analysis methods as needed and create protocols for routine and non-routine analysis.

The Opportunity:

As a 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, validate methods, and implement new procedures to support GMP production
• Draft and review documentation for equipment qualification, method implementation, and procedures
• Collaborate with Technical Development Teams (TDTs), PTC functions, 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
• Develop new 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
  
  

Who You Are:

• You possess a Bachelor’s degree and 5 years of relevant QC experience (or a Master’s with 3 years); degrees in Chemistry, Biochemistry, Molecular Biology or relevant scientific discipline are preferable
• You possess experience working in the pharmaceutical or biopharmaceutical industry
• You are proficient in running and validating molecular methods, specifically for flow cytometry and cell culture-based assays
• You have a solid understanding of cGMPs or similar regulations
• You possess excellent verbal and written communication skills, with the ability to effectively present information
• 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 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
  
  

Relocation benefits are not approved for this posting.

This is an on-site position.

The expected salary range for this position based on the primary location of Oregon is $68,300 (min) - $97,600 (mid) - $126,900 (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 in this link.

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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.

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