Overview

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.
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!

Codexis

Open Positions at Codexis

Sr. Scientist, Quality Control