Sr. Scientist, Quality Control

Abgenix; 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 up to 4%

Company Equity

Generous Paid Time Off incl. holidays

Job summary

Codexis Inc in Redwood City, CA seeks a Sr. Scientist to lead analytical method transfer and validation for oligonucleotide and enzyme products. This on-site role will help build the QC lab in a GMP facility, with future moves or hybrid work between Redwood City and Hayward.

The candidate will manage method lifecycle, method validation strategies, and oversee analytical instrumentation. Strong leadership and cross-functional collaboration are required.

Qualifications

• PhD or equivalent with 4+ years in a regulated environment.
• Working knowledge of cGMP and ICH guidelines.
• Proven experience in developing analytical method validation strategies and execution.
• Deep technical knowledge of LC-MS, IP-RP-HPLC and AEX chromatography for oligonucleotide analysis.
• Strong analytical techniques for biological products (ELISA, qPCR, UV-Vis, CE-SDS, HPLC, GC).

Responsibilities

• Lead analytical method transfers and validation activities with protocol design, execution and reporting.
• Author transfer/validation protocols, technical reports, SOPs and regulatory filing sections.
• Manage lifecycle of analytical methods and instruments, including qualification and change control.
• Perform advanced analytical testing for raw materials, in-process, and finished products.
• Provide technical oversight for QC analytical methods and instrumentation; troubleshoot deviations and investigations.
• Design, execute, and oversee stability programs with data review and reporting.
• Support QC systems and laboratory practices across ISO 9001 and GMP transition.

Skills

PhD life sciences

cGMP knowledge

Analytical method validation

LC-MS

IP-RP-HPLC

AEX chromatography

ELISA

qPCR

UV-Vis

CE-SDS

HPLC

GC

Education

PhD in life sciences/chemistry/biochemistry

MS/BS with 10+ years in regulated env

Tools

LC-MS

IP-RP-HPLC

AEX chromatography

Job 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

Department 64 - Quality Control Employment Type Full Time Location Redwood City, CA Workplace type Onsite Compensation $160,000 - $175,000 / year

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

About Codexis Inc

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.

Our Hiring Process

Background Check

Stage 8: Hired

Stage 1: Applied

Stage 2: Application Review

Stage 3: Preliminary Screen

Stage 4: First Interview

Stage 5: Full Round Interview

Stage 6: Offer

Stage 8: Hired