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!
