Cell Therapy QC Analyst - GMP Lab & Validation

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

Benefits offered by this job

Health care

Vision/Dental

Retirement plan

PTO

Job summary

Bayer is seeking a Quality Control Analyst in Berkeley, CA to perform GMP analytical testing of cell therapy products in the site laboratory. You will conduct product release and in-process testing, manage sample administration in SAP/LIMS, and support method validations and data integrity per cGMP.

The role requires a B.S. in a related field with hands-on flow cytometry experience and knowledge of USP/EP/JP where applicable. 8:00 AM–4:30 PM, M-F; salary range $93,840–$125,000 with benefits.

Qualifications

• B.S. in Biological Sciences, Biochemistry, Molecular Biology, Chemistry, or related field required.
• Hands-on flow cytometric assays for cell therapy products expected.
• Strong knowledge of GLP/GMP guidelines as applied to biologics testing.
• Excellent verbal and written communication for scientific reporting.

Responsibilities

• Perform GMP analytical testing of cell therapy products using flow cytometers and ddPCR.
• Test raw materials, starting materials, intermediates and final products such as CAR-T cells and iPSC.
• Support QC/QA, regulatory compliance, and data integrity in LIMS or SAP systems.
• Design/execute experiments and ensure accurate documentation per cGMPs.

Skills

Flow cytometry

GLP/GMP knowledge

Scientific reporting

Communication skills

Education

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

M.S. in Biological Sciences, Molecular Biology, Biochemistry, Chemistry, or related field (preferred)

Tools

LIMS

SAP

qPCR/ddPCR

Job description

Bayer is seeking a Quality Control Analyst in Berkeley, CA to perform GMP analytical testing of cell therapy products in the site laboratory. You will conduct product release and in-process testing, manage sample administration in SAP/LIMS, and support method validations and data integrity per cGMP.

The role requires a B.S. in a related field with hands-on flow cytometry experience and knowledge of USP/EP/JP where applicable. 8:00 AM–4:30 PM, M-F; salary range $93,840–$125,000 with benefits.