Sr. Scientist, Quality Control Department: 64 - Quality Control Employment Type: Full Time Location: Redwood City, CA Compensation: $160,000 - $175,000 / year Description The Sr. Scientist in Quality Control will be lead…
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$160k–$175k/yr
Full-time
bachelor degree, postgraduate degree
Medical Insurance, Dental Insurance, Vision Insurance, Basic Life Insurance, AD&D Insurance, Short-Term Disability Insurance
Posted 46d ago
~40 hrs/week
Responsibilities
Lead analytical method transfer and validation for oligonucleotide therapeutics and enzyme products within a GMP environment. Provide technical oversight for QC instrumentation, manage stability programs, and support the transition to GMP-compliant operations.
Requirements
Requires a Ph.D. with 4+ years of industry experience or a B.S./M.S. with 10+ years of experience in a regulated environment. Must possess deep technical expertise in LC-MS, HPLC, and various biological analytical techniques along with working knowledge of cGMP and ICH guidelines.
Full job description
Sr. Scientist, Quality Control
Department: 64 - Quality Control
Employment Type: Full Time
Location: Redwood City, CA
Compensation: $160,000 - $175,000 / year
Description
The Sr. Scientist in Quality Control will be leading analytical method transfer and validation for oligonucleotide therapeutic and enzyme products. This role serves as a subject matter expert for analytical methods and instrumentation within Quality and will help leading the design and implementation of the QC laboratory in a GMP manufacturing facility. This is an on-site position initially be based in Redwood City, CA, with the potential to transition to our Hayward location in the future or operate in a hybrid capacity across both sites.
We would love to meet candidates who bring: • Strong scientific judgment and analytical problem-solving skills • GMP quality mindset with a focus on compliance and execution • Adaptability and leadership in a fast-paced environment • Clear communication and cross-functional collaboration
Key Responsibilities
Lead analytical method transfers and method validation activities, including protocol design, execution and reporting.
Manage the lifecycle of analytical methods and laboratory instruments, including qualification, maintenance, change control to support GMP readiness.
Perform advanced analytical testing for raw materials, in-process and finished products.
Provide technical oversight for QC analytical methods and instrumentation, including troubleshoot, root cause analysis, deviations and OOS/OOT investigations.
Design, execute, and oversee stability programs, including protocol development, study execution, data review, trend evaluation, and technical reporting.
Support QC systems, documentation, laboratory practices, and analytical controls across both the ISO 9001 quality site and the transition to GMP-compliant operations.
Additional experience that would be valuable for this role includes:
Experience with microbiological testing and environmental monitoring, or related GMP laboratory controls.
Experience supporting the buildout, expansion, or operational readiness of analytical laboratories.
Skills, Knowledge & Expertise
Ph.D. in life sciences, chemistry, biochemistry, or a related field with 4+ years of relevant industry experience in regulated environment; or M.S./B.S. with 10+ years of relevant experience.
Working knowledge of cGMP and ICH guidelines.
Proven experience in developing analytical method validation strategies and execution.
Deep technical knowledge and working experience in LC-MS, IP-RP-HPLC and AEX chromatography for oligonucleotide analysis.
Strong scientific background in analytical techniques for biological products, including ELISA, qPCR, UV-Vis, CE-SDS, HPLC, and GC.
Job Benefits
Medical, Dental and Vision Insurance
Basic Life, AD&D, Short- and Long-Term Disability Insurance
401k with Company Match up to 4%
Company Equity
Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time
Annual Lifestyle Account for reimbursement of fitness programs, equipment and more
Employee Stock Purchase Program (ESPP)
Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)
Student Debt Program (Company Contribution to Loans)
Mental Health Wellness Program
Subsidized onsite lunch program
Onsite Gym Facilities
Paid Parental Leave
And More!
Related keywords
Quality ControlcGMPICH GuidelinesOligonucleotideEnzyme ProductsMethod ValidationLC-MSHPLCAEX ChromatographyELISAqPCRUV-VisCE-SDSGCISO 9001Root Cause Analysis
Codexis is redefining what is possible in therapeutic development and manufacturing, leading the technology revolution with efficient,
high-quality, and commercially proven solutions. The company’s manufacturing platforms consistently outperform legacy
methods, enabling the development of therapeutic possibilities that were previously out of reach. With a proven track record, proprietary technology, and unrivalled scientific expertise, Codexis advances beyond conventional boundaries. More than a solutions provider, Codexis serves as a trusted long-term partner, committed to driving progress across complex therapeutic development and manufacturing.
Offices: 200 Penobscot Drive, Redwood City, CA 94063, US
Codexis is redefining what is possible in therapeutic development and manufacturing, leading the technology revolution with efficient,
high-quality, and commercially proven solutions. The company’s manufacturing platforms consistently outperform legacy
methods, enabling the development of therapeutic possibilities that were previously out of reach. With a proven track record, proprietary technology, and unrivalled scientific expertise, Codexis advances beyond conventional boundaries. More than a solutions provider, Codexis serves as a trusted long-term partner, committed to driving progress across complex therapeutic development and manufacturing.
Offices: 200 Penobscot Drive, Redwood City, CA 94063, US
