Senior QC Specialist - 238842

About the CompanyJoin a newly-established in-house QC team at a growing biologics company in Redwood City, CA. Collaborate with teammates to continue developing and building out the new in-house QC testing lab. As a senior team member, in addition to conducting QC analysis benchwork, contribute via QC protocol development, overseeing outsourced QC testing, review of method transfer/ method qualification, leading QC-related QMS activities, and more. ResponsibilitiesServe as a team proficiency expert for ddPCR (droplet digital PCR) and other molecular based and cell based QC assays for batch release, stability testing, and product characterization purposes. Review internal GMP analytical testing and method qualification. Collaborate with Analytical Development on assay development and troubleshooting.Provide oversight for external QC testing at third party labs / CMO.Develop QC protocols and SOPs as needed. Lead Lab deviation investigations, CAPAs, change controls and other QMS activities.Coordinate lab equipment qualification and validation activities. QualificationsBS degree and 8 years, MS degree and 6 years, or PhD and 4 years of Quality Control or Analytical Development experience with Biologics.Required SkillsProficiency in ddPCR (Droplet Digital PCR) and expertise in molecular and cell-based assays such as flow cytometry, ELISA, etc.Industry experience working in cGMP environment in Quality Control or Analytical DevelopmentStrong background in Biologics, Cell therapy, CAR-T, etc. Preferred SkillsAbility to troubleshoot and/or develop assaysExperience overseeing QC work outsourced to third party labs/CMOs

Created: 2025-02-20