Cell Therapy QC Analyst (cGMP, Flow Cytometry)

Bayer AG; Berkeley (CA); On-site; USD 94,000 - 125,000; Full time

Job summary

Bayer AG is seeking a QC Analyst to perform GMP analytical testing of cell therapy products at our Berkeley, CA site. You will conduct release and in-process tests, calibrate equipment, manage samples in SAP/LIMS, and perform root cause analyses for nonconformities.

The role requires hands-on flow cytometry experience, GMP knowledge, and excellent communication to support cross‑functional teams in a fast-paced, regulated environment.

Qualifications

• B.S. in Biological Sciences, Biochemistry, Molecular Biology, Chemistry, or related field.
• Demonstrated expertise in flow cytometric assays for cell therapy products.
• Thorough knowledge of GLP/GMP guidelines as applied to biologics testing.
• Excellent verbal and written communication skills including scientific reporting.

Responsibilities

• Perform GMP analytical testing of cell therapy products using flow cytometers, microscopy, and ddPCR.
• Test raw materials, starting materials, process intermediates, and CAR-T/iPSC products.
• Provide technical support for QC with knowledge of USP/NF, EP, JP.
• Follow SOPs and cGMP requirements, report abnormalities.
• Execute method validations/transfers and manage discrepancies.
• Maintain accurate documentation in LIMS and other databases.
• Operate and troubleshoot analytical instruments.
• Design and conduct complex experiments and communicate findings.
• Collaborate with Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety.

Skills

Flow cytometry

cGMP/GLP

Data analysis & reporting

Lab testing

Interdepartmental collaboration

Cell therapy knowledge

Education

Bachelor's in Biological Sciences

Master's in Biological Sciences

Tools

SAP

LIMS

Job description

Bayer AG is seeking a QC Analyst to perform GMP analytical testing of cell therapy products at our Berkeley, CA site. You will conduct release and in-process tests, calibrate equipment, manage samples in SAP/LIMS, and perform root cause analyses for nonconformities.

The role requires hands-on flow cytometry experience, GMP knowledge, and excellent communication to support cross‑functional teams in a fast-paced, regulated environment.