Quality Control Analyst - Berkeley, CA

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

Quality Control Analyst - Berkeley, CA

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

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 10-19-26.

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.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

Bayer is an E-Verify Employer.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 892861

Contact Us

Email: [e-mail]