Senior Analyst, QC Cell and Molecular Biology (Biotech)

TL;DR

Senior Analyst, QC Cell and Molecular Biology (Biotech): Execute core QC laboratory testing including qPCR, ddPCR, ELISA, flow cytometry, and potency assays for release and stability of AlloCAR T products with an accent on GMP compliance, assay troubleshooting, and lab maintenance. Focus on performing end-to-end PCR workflows, managing sample chain of custody, and supporting discrepancy investigations.

Location: Onsite in Newark, CA. Must be authorized to work in the U.S.

Salary: From $45.00 to $53.00 per hour

Company

Clinical-stage biotechnology company pioneering allogeneic CAR T cell therapies for cancer and autoimmune disease.

What you will do

• Perform QC analytical testing including qPCR, ddPCR, ELISA, potency, cell culture, and flow cytometry to support product release and stability.
• Execute end-to-end PCR workflows, validate and troubleshoot assays, interpret results using software and spreadsheets.
• Maintain GMP lab compliance by monitoring equipment, reagents, inventories, and performing maintenance and 5S activities.
• Manage GMP and non-GMP sample chain of custody and document all activities accurately per cGMP.
• Support discrepancy management, investigations, CAPA, SOP revisions, assay training, and audit readiness.
• Collaborate with cross-functional teams including QA, Process Development, and Manufacturing.

Requirements

• B.S. in scientific discipline with 4+ years in cGMP environment.
• Demonstrated hands-on experience with PCR, ddPCR, flow cytometry, and other cell/molecular biology techniques.
• Experience maintaining GMP labs, equipment, pipettes, supplies, and supporting OOS/OOE investigations.
• Proficiency in authoring SOPs, change management, precise documentation, and troubleshooting.
• Strong organizational, communication, and problem-solving skills; team player able to manage multiple tasks.
• Authorized to work in the U.S.

Culture & Benefits

• Work with talented people in a collaborative, fast-paced environment.
• 9-month contract with possibility of extension.
• Focus on delivering off-the-shelf cell therapies at scale.