We are hiring for a
Scientist, Reagent Quality Control to join our growing team. This role will lead the development, optimization, and execution of QC methods for incoming inspection and in-house reagent production. You will lead the development and execution of analytical methods - FPLC, HPLC, gel electrophoresis, and plate-based assays, and functional sequencing assays to support reagent QC. You will own the batch records and documentation for all QC performed and drive continuous improvement of these documents and methods. You will also develop and optimize release criteria and specifications, analyze data across multiple lots, and lead troubleshooting, nonconformance (NC), CAPA, and root-cause investigations to closure. This position reports to the Director of Operations and is located in San Carlos, CA.
Responsibilities- Develop, optimize, and execute FPLC, HPLC and plate-based assays to support reagent QC and new reagent validation.
- Lead lot release, stability testing, and qualification of critical reagents.
- Develop and define QC release criteria, specifications, and acceptance limits for reagents, partnering with R&D and Operations.
- Lead nonconformance (NC) and out-of-specification (OOS) investigations with structured root-cause analysis, and drive corrective and preventive actions (CAPA) to closure.
- Support deviation handling, change control, and method qualification/validation in line with the quality system.
- Design and develop new analytical methods, drive optimization of existing QC methods, and mentor junior team members.
- Ensure data quality and integrity by establishing best practices and maintaining a high standard of organization and detail.
- Maintain and organize work areas, including hoods, benches, chemical storage, and waste disposal. Support calibration and maintenance of laboratory instruments.
- Problem-solving: Independently troubleshoot and perform root-cause analysis on failed assays or equipment malfunctions, and design the experiments needed to resolve them.
- Author and own Standard Operating Procedures, Test Methods, Development Reports, and other documentation.
Required Qualifications- PhD in Chemistry, Biochemistry, or a related field with 2+ years of relevant industry experience; or an MS with 4+ years of relevant industry experience.
- Experience with HPLC and/or FPLC (AKTA), gel electrophoresis, BLI, and plate-based assays.
- Hands-on experience developing QC release criteria, specifications, and acceptance limits, and executing method qualification/validation.
- Working knowledge of quality-system processes - nonconformance (NC), CAPA, root-cause analysis, OOS investigations, and change control.
- Ability to work independently, lead projects, and collaborate as part of a team.
- Desire to work in a highly cross-functional, fast-paced environment.
- Willingness to learn and grow within a transformative company.
