Genentech · 2 days ago
Quality Control Analyst - Potency Assays
Hillsboro, OR
Full-time
Onsite
Entry, Mid Level
$68K/yr - $127K/yr
2+ years expGenentech is a leading company in the field of cell and gene therapies. The Quality Control Analyst will conduct analytical testing and ensure data integrity and compliance while supporting the clinical progress of therapies through various quality control activities.
BiotechnologyLife ScienceManufacturing
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
Qualification
Required
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
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
Preferred
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)
Benefits
Relocation benefits are approved for this posting.
A discretionary annual bonus may be available based on individual and Company performance.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
CEO
Michael Laird
Vice President
Recent News
2025-12-30
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2025-12-24
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