Quality Control Analyst - Berkeley, CA

Bayer•Berkeley, CA

2d•$93,840 - $125,000•Onsite

About The Position

Join Bayer as a Quality Control Analyst at its Berkeley production site, conducting chemical and physical analyses in the laboratory. The role supports quality control testing for cell therapy, commercial rFVIII, and CCTC products. Work includes product-release and in-process control testing, stability testing, maintaining and calibrating analytical equipment, administering samples in SAP/LIMS, and performing root-cause analyses for 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 focuses on GMP analytical testing of cell therapy products, including methods using flow cytometers, microscopic technologies, and ddPCR. It involves testing raw materials, starting materials, process intermediates, and final products such as CAR-T cells and iPSCs. The analyst provides technical scientific support to QC functional areas, maintains subject-matter expertise in applicable compendia, and works with teams across Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety. The stated shift is 8:00 AM–4:30 PM, Monday through Friday. Flexibility to support business needs, including occasional weekend work, is required. The position is based in Berkeley, California.

Requirements

Bachelor of Science 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.
Master of Science 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 using methods including flow cytometry, microscopy, 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 for instruments.
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 preventive actions.
Execute method validations and transfers and support computer system validation.
Maintain accurate documentation in accordance with cGMP requirements, including raw-data control and archiving.
Prepare and support the creation of GMP documents and regulations.
Provide technical scientific support to QC functional areas and maintain subject-matter expertise in USP/NF, EP, and JP compendia.
Follow SOPs and cGMP requirements and report abnormalities.
Independently design and conduct experiments, assays, or operational procedures of considerable complexity.
Communicate complex scientific findings and recommendations effectively in various settings.
Collaborate with Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety.
Support business needs with occasional weekend work when required to meet operational timelines.