Cell Therapy Quality Control Analyst - GMP & Flow Cytometry

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

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer in Berkeley, CA seeks a Quality Control Analyst to conduct GMP analytical testing of cell therapy products, including CAR-T and iPSC, at our production site laboratory. You will perform release and in-process tests, calibrate equipment, and manage samples in SAP/LIMS, contributing to cGMP documentation and validation activities.

The role requires a BS in a biological science, hands-on flow cytometry experience, and strong written/verbal communication.

Qualifications

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

Responsibilities

• Perform GMP analytical testing of cell therapy products using flow cytometry and related methods.
• Test raw materials, starting materials, process intermediates, and final products (CAR-T, iPSC).
• Support QC/QA, method validation, and data review in LIMS or databases.
• Maintain and calibrate analytical equipment and manage sample administration in SAP/LIMS.
• Prepare and review GMP documentation and regulatory compliance materials.

Skills

Flow cytometry

Communication (verbal & written)

GLP/GMP knowledge

Education

B.S. in Biological Sciences / Biochemistry / Molecular Biology / Chemistry or related field

M.S. in Biological Sciences / Molecular Biology / Biochemistry / Chemistry (preferred)

Tools

SAP

LIMS

Job description

Bayer in Berkeley, CA seeks a Quality Control Analyst to conduct GMP analytical testing of cell therapy products, including CAR-T and iPSC, at our production site laboratory. You will perform release and in-process tests, calibrate equipment, and manage samples in SAP/LIMS, contributing to cGMP documentation and validation activities.

The role requires a BS in a biological science, hands-on flow cytometry experience, and strong written/verbal communication.