Quality Control Analyst - Berkeley, CA

Bayer•Berkeley, CA

1d•$93,840 - $125,000•Onsite

About The Position

The Quality Control Analyst conducts chemical and physical analyses in a production-site laboratory and supports quality control testing of cell therapy, commercial rFVIII, and CCTC products. The role includes product release and in-process control testing, stability testing, analytical equipment maintenance and calibration, sample administration in SAP/LIMS, and root cause analysis of nonconformities. The analyst also supports GMP operations through computer system and method validation, raw data control and archiving, and preparation of GMP documents and regulations. The position performs GMP analytical testing of cell therapy products, including methods using flow cytometers, microscopic technologies, and ddPCR. Testing covers raw materials, starting materials, process intermediates, and final products such as CAR-T cells and iPSCs. The analyst provides technical scientific support across QC functions, maintains expertise in USP/NF, EP, and JP compendia, and works with departments including Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety. The schedule is 8:00 a.m. to 4:30 p.m., Monday through Friday, with flexibility to support occasional weekend work when needed for operational timelines. The position is based in Berkeley, California.

Requirements

B.S. in Biological Sciences, Biochemistry, Molecular Biology, Chemistry, or a related field.
Demonstrated expertise and hands-on experience in flow cytometric assays for characterization of cell therapy products.
Thorough knowledge of GLP/GMP guidelines as applied to testing biologic molecules.
Excellent verbal and written communication skills, including the ability to write scientific and technical reports.

Nice To Haves

At least 6 years of relevant experience in a biopharma, healthcare, or manufacturing environment.
M.S. in Biological Sciences, Molecular Biology, Biochemistry, Chemistry, or a related field, with at least 2 years of relevant experience in a biopharma, healthcare, or manufacturing environment.
Experience with other analytical methods for cell therapy products, such as cell-based functional assays, quantitative PCR/ddPCR assays, quantitative imaging assays, or virology.
Hands-on experience handling human cells or cell lines, including PBMC, CAR-T cells, and iPSC.
Thorough knowledge of compendial requirements (USP, EP, JP), ACS, and FCC requirements.

Responsibilities

Perform GMP analytical testing of cell therapy products, particularly using flow cytometers, microscopic technologies, and ddPCR.
Test raw materials, starting materials, process intermediates, and final cell therapy products, including CAR-T cells and iPSCs.
Conduct product release, in-process control, and stability testing.
Maintain and calibrate analytical equipment, and demonstrate operation, maintenance, and troubleshooting skills.
Manage sample administration in SAP/LIMS and compile and review data in LIMS or other databases.
Perform root cause analyses for nonconformities, manage discrepancies, and implement corrective and preventative actions.
Execute method validations and transfers and support computer system validation.
Follow SOPs and cGMP requirements, report abnormalities, and maintain complete and accurate documentation.
Control and archive raw data and create GMP documents and regulations.
Provide technical scientific support for QC functional areas and maintain subject matter expertise in USP/NF, EP, and JP compendia.
Independently design and conduct experiments, assays, or operational procedures of considerable complexity.
Communicate complex scientific findings and recommendations effectively in various settings.
Interact with Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety departments.
Support business needs, including occasional weekend work when required to meet operational timelines.