Cell Therapy QC Analyst — GMP Analytics & Flow Cytometry

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

Benefits offered by this job

Health care

Vision

Dental

Retirement plan

PTO

Sick leave

Job summary

Bayer AG in Berkeley is seeking a QC Analyst to perform GMP analytical testing of cell therapy products, including methods using flow cytometers, ddPCR, and microscopic techniques. You will manage sample administration in SAP/LIMS, support validation, and ensure cGMP compliance while collaborating with Quality Control, QA, and Operations.

Shift hours 8:00 AM–4:30 PM, Monday–Friday. Salary range $93,840.00–$125,000.00 with potential bonus; employees receive health care, PTO, retirement, and other

Qualifications

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

Responsibilities

• Perform GMP analytical testing of cell therapy products using flow cytometers, microscopic technologies, and ddPCR.
• Test raw materials, starting materials, process intermediates, and final cell therapy products (e.g., CAR-T cells, iPSCs).
• Provide technical scientific support for QC functions; maintain SME for USP/NF, EP, JP.
• Follow SOPs, ensure cGMP compliance, report abnormalities; execute validations and transfers.
• Maintain accurate documentation in LIMS/databases; support CAPA activities.
• Interact with Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, Safety.

Skills

Flow cytometry

Cell therapy

GMP/GLP

Technical writing

SOP compliance

Education

B.S. in Biological Sciences

M.S. in Biological Sciences

Job description

Bayer AG in Berkeley is seeking a QC Analyst to perform GMP analytical testing of cell therapy products, including methods using flow cytometers, ddPCR, and microscopic techniques. You will manage sample administration in SAP/LIMS, support validation, and ensure cGMP compliance while collaborating with Quality Control, QA, and Operations.

Shift hours 8:00 AM–4:30 PM, Monday–Friday. Salary range $93,840.00–$125,000.00 with potential bonus; employees receive health care, PTO, retirement, and other