Quality Control Analyst - Berkeley, CA

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

Benefits offered by this job

Health care

Vision

Dental

Retirement plan

PTO

Sick leave

Job summary

Bayer AG in Berkeley is seeking a QC Analyst to perform GMP analytical testing of cell therapy products, including methods using flow cytometers, ddPCR, and microscopic techniques. You will manage sample administration in SAP/LIMS, support validation, and ensure cGMP compliance while collaborating with Quality Control, QA, and Operations.

Shift hours 8:00 AM–4:30 PM, Monday–Friday. Salary range $93,840.00–$125,000.00 with potential bonus; employees receive health care, PTO, retirement, and other

Qualifications

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

Responsibilities

• Perform GMP analytical testing of cell therapy products using flow cytometers, microscopic technologies, and ddPCR.
• Test raw materials, starting materials, process intermediates, and final cell therapy products (e.g., CAR-T cells, iPSCs).
• Provide technical scientific support for QC functions; maintain SME for USP/NF, EP, JP.
• Follow SOPs, ensure cGMP compliance, report abnormalities; execute validations and transfers.
• Maintain accurate documentation in LIMS/databases; support CAPA activities.
• Interact with Quality Control, Quality Assurance, Supply Chain, Operations, Engineering, Maintenance, Safety.

Skills

Flow cytometry

Cell therapy

GMP/GLP

Technical writing

SOP compliance

Education

B.S. in Biological Sciences

M.S. in Biological Sciences

Job description

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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 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.

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