Quality Control Analyst - Berkeley, CA

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

Job summary

Bayer AG is seeking a QC Analyst to perform GMP analytical testing of cell therapy products at our Berkeley, CA site. You will conduct release and in-process tests, calibrate equipment, manage samples in SAP/LIMS, and perform root cause analyses for nonconformities.

The role requires hands-on flow cytometry experience, GMP knowledge, and excellent communication to support cross‑functional teams in a fast-paced, regulated environment.

Qualifications

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

Responsibilities

• Perform GMP analytical testing of cell therapy products using flow cytometers, microscopy, and ddPCR.
• Test raw materials, starting materials, process intermediates, and CAR-T/iPSC products.
• Provide technical support for QC with knowledge of USP/NF, EP, JP.
• Follow SOPs and cGMP requirements, report abnormalities.
• Execute method validations/transfers and manage discrepancies.
• Maintain accurate documentation in LIMS and other databases.
• Operate and troubleshoot analytical instruments.
• Design and conduct complex experiments and communicate findings.
• Collaborate with Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety.

Skills

Flow cytometry

cGMP/GLP

Data analysis & reporting

Lab testing

Interdepartmental collaboration

Cell therapy knowledge

Education

Bachelor's in Biological Sciences

Master's in Biological Sciences

Tools

SAP

LIMS

Job description

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At Bayer, we believe work should matter. Every day, our teams push toward a future where "Health for all, Hunger for none" is within reach, and every role, from the lab to the field to the boardroom, helps us get there. We give people the ownership to shape outcomes, the support to grow through new skills and experiences, and a global community where different perspectives are valued. If you want your work to count and the room to become your best, you'll find it here.

Join our team as a QC Analyst, where you will play a crucial role in conducting chemical and physical analyses in our production site laboratory. Your responsibilities will include performing product release and in-process control tests, conducting stability tests, maintaining and calibrating analytical equipment, managing sample administration in SAP/LIMS, and performing root cause analyses for nonconformities. Additionally, you will support GMP operations through computer system validation, method validation, raw data control and archiving, and the creation of GMP documents and regulations. This position supports the quality control testing of cell therapy, commercial rFVIII, and CCTC products.

YOUR TASKS AND RESPONSIBILITIES:

• Perform GMP analytical testing of cell therapy products, focusing on methods using flow cytometers, microscopic technologies, and ddPCR;
• Conduct testing of raw materials, starting materials, process intermediates, and final cell therapy products such as CAR-T cells and iPSCs;
• Provide technical scientific support for QC functional areas, maintaining subject matter expertise for USP/NF, EP, and JP compendia;
• Follow SOPs accurately, perform activities in accordance with cGMP requirements, and report abnormalities;
• Execute method validations and transfers, manage discrepancies, and implement corrective and preventative actions;
• Keep accurate documentation to ensure completeness and accuracy per cGMPs, compile and review data in LIMS or other databases;
• Demonstrate knowledge of operation, maintenance, and troubleshooting skills for analytical instruments;
• Independently design and conduct experiments, assays, or operational procedures of considerable complexity;
• Communicate complex scientific findings and recommendations effectively in various settings;
• Interact with multiple departments such as Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, and Safety.

WHO YOU ARE:

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• B.S. in Biological Sciences, Biochemistry, Molecular Biology, Chemistry, or 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 the testing of biologics molecules;
• Excellent verbal and written communication skills including writing of scientific and technical reports.

Preferred Qualifications:

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

Shift hours: 8:00 AM – 4:30 PM, Monday through Friday.
Candidates must be flexible to support business needs, including occasional weekend work when required to meet operational timelines.

Employees can expect to be paid a salary between $93,840.00 - $125,000.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.
This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
This posting will be available for application until at least 10-28-26.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

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