Sr. Scientist, Quality Control

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.
• 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!