Quality Control Analyst Berkeley, CA

At Bayer were visionaries driven to solve the worlds toughest challenges and striving for a world where Health for all Hunger for none is no longer a dream but a real possibility. Were 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 youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference theres only one choice.

Quality Control Analyst - Berkeley CA

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 beflexible to support business needs including occasional weekend work when required to meet operational timelines.

Employees can expect to be paid a salary between $93840.00 - $125000.00. 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 applicants location market data/ranges an applicants skills and prior relevant experience certain degrees and certifications and other relevant factors.
This posting will be available for application until at least.

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