Quality Control Analyst - Berkeley, CA
Bayer
Summary
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.
Job description
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
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
Requirements
- 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
- A minimum of 6 years relevant experience in biopharma, healthcare, or manufacturing environment (preferred)
- M.S. in Biological Sciences, Molecular Biology, Biochemistry, Chemistry, or related field with a minimum of 2 years relevant experience (preferred)
- Experience in other analytical methods for cell therapy products (preferred)
- Hands-on experience in handling human cells/cell lines including PBMC, CAR-T cells, iPSC (preferred)
- Thorough knowledge of compendial requirements (USP, EP, JP), ACS, and FCC requirements (preferred)
Benefits
- Health care
- Vision
- Dental
- Retirement
- PTO
- Sick leave
Company overview
Bayer AG is a global life science company with core competencies in healthcare and agriculture, operating as one of the world's leading pharmaceutical corporations. Founded in 1863 and headquartered in Leverkusen, Germany, Bayer operates through three primary divisions: Pharmaceuticals, Consumer Health, and Crop Science. The company's pharmaceutical segment focuses on prescription products for cardiology, women's healthcare, oncology, hematology, and ophthalmology, with blockbuster drugs including Xarelto, Eylea, and Nubeqa. Bayer's Consumer Health division markets well-known over-the-counter brands such as Aspirin, Aleve, Claritin, and Bepanthen. The Crop Science division, strengthened by the acquisition of Monsanto, provides seeds, crop protection products, and digital farming solutions. With approximately 92,815 employees worldwide and operations in 80 countries, Bayer is committed to its mission of "Health for all, Hunger for none," driving innovation in medical treatments, agricultural productivity, and sustainable development. The company maintains a strong research and development pipeline, investing heavily in areas like precision medicine, artificial intelligence applications in healthcare, and sustainable agricultural technologies.