The Role
Lead analytical method transfer and validation for oligonucleotide and enzyme products; author protocols, SOPs and regulatory reports; manage analytical methods and instruments lifecycle for GMP readiness; perform advanced QC testing; oversee stability programs; troubleshoot and investigate deviations/OOS; support QC systems, documentation, and lab buildout for GMP-compliant operations.
Summary Generated by Built In
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
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.
- Author transfer/validation protocols, technical reports, SOPs and relevant regulatory filing sections.
- 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!
About
Why join Codexis?At Codexis we offer a very competitive compensation package and beyond excellent benefits! We foster career growth, continued education and upskilling through our mentorship program and learning and development opportunities. You will learn and work alongside inspirational leaders and colleagues who are equally passionate about our mission and committed to fostering an inclusive, growth-centered, and rewarding culture. Diversity is valued and mutual trust is of paramount importance to the ethos at Codexis. The people, the culture and working with others with a common goal is what makes Codexis a great place to work.For more information, visit www.codexis.com.Codexis is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
Skills Required
- Ph.D. in life sciences, chemistry, biochemistry, or related field with 4+ years industry experience; or M.S./B.S. with 10+ years relevant experience.
- Working knowledge of cGMP and ICH guidelines.
- Proven experience developing analytical method validation strategies and executing validations.
- Deep technical experience with LC-MS, IP-RP-HPLC and AEX chromatography for oligonucleotide analysis.
- Strong background in analytical techniques for biological products including ELISA, qPCR, UV-Vis, CE-SDS, HPLC, and GC.
- Experience leading analytical method transfers, protocol design, execution and reporting.
- Experience with microbiological testing and environmental monitoring or related GMP laboratory controls.
- Experience supporting buildout, expansion, or operational readiness of analytical laboratories.
- GMP quality mindset, leadership, adaptability, clear communication and cross-functional collaboration.
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The Company
What We Do
Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® platform to discover and develop novel, high performance enzymes and novel biotherapeutics. Codexis enzymes have applications in the sustainable manufacturing of pharmaceuticals, food, and industrial products; in the creation of the next generation of life science tools; and as gene therapy and biologic therapeutics. The Company’s unique performance enzymes drive improvements such as: reduced energy usage, waste generation and capital requirements; higher yields; higher fidelity diagnostics; and more efficacious therapeutics. Codexis enzymes enable the promise of synthetic biology to improve the health of people and the planet
