Sr. Scientist, Quality Control

Codexis, Inc.; Redwood City (CA); On-site; USD 160,000 - 175,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401k with Company Match

Generous Paid Time Off

Annual Lifestyle Account for fitness

Employee Stock Purchase Program

Mental Health Wellness Program

Subsidized onsite lunch program

Onsite Gym Facilities

Paid Parental Leave

Job summary

Codexis, Inc. seeks a Sr. Scientist in Quality Control to lead analytical method transfer and validation in Redwood City, CA. Candidates should possess a Ph.D. with 4+ years of experience or an M.S./B.S. with 10+ years in regulated environments. Responsibilities include leading method validation, managing instruments, and overseeing QC practices.

Benefits include medical and dental insurance, 401k with company match, generous paid time off, and more.

Qualifications

• 4+ years of relevant industry experience in regulated environments for Ph.D.
• 10+ years of relevant experience for M.S./B.S.
• Deep technical knowledge in oligonucleotide analysis.

Responsibilities

• Lead analytical method transfers and validation activities.
• Author transfer/validation protocols and technical reports.
• Manage lifecycle of analytical methods and instruments.
• Perform advanced analytical testing for products.
• Provide technical oversight for QC analytical methods.

Skills

Analytical problem-solving skills

Strong scientific judgment

GMP quality mindset

Leadership in fast-paced environment

Cross-functional collaboration

Education

Ph.D. in life sciences, chemistry, or a related field

M.S. / B.S. with 10+ years of relevant experience

Tools

LC-MS

HPLC

GC

ELISA

qPCR

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 lead the design and implementation of the QC laboratory in a GMP manufacturing facility. This is an on-site position initially 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