Job description
This is a stellar opportunity within an established and thriving BioPharma company manufacturing large scale monoclonal antibody biotherapeutics and vaccines. The ideal candidate would perform Quality Control assays for product release, maintain data throughout testing, and assuring strict adherence to cGMP regulations. Additionally, responsibilities will include:
Performing QC testing of Cell Therapy release and stability samples.- Writing original and revising current SOPs, forms, and test records.
- Writing edits and approving Deviations and CAPAs, as required.
- Responsible for initiating Change Controls and completing the necessary documentation.
- Actively participating in training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols
- Initiating Out of Specification (OOS), Cell Review Committee (CRC), and deviation investigations as needed to address nonconformances in the lab.
- Ordering supplies and reagents.
- Performing general lab and equipment maintenance duties.
Minimum Requirements:
Bachelor?s degree in Biology, Chemistry, Engineering, or a related scientific discipline.- Demonstrated knowledge of biological, cell-based assays including but not limited to flow cytometry, proliferation, ELISA, cell counts, and immunofluorescence microscopy/spectroscopy.
- In-depth knowledge of cGMP principles, and ability to provide corrective action when standards are breached.
- Working knowledge of methods execution/procedures and equipment operation.
- Knowledge of basic and specialized laboratory equipment.
- Prior experience with SAP and Trackwise systems a plus.
- Advanced process improvement and problem-solving capabilities.
- Ability to record test results, maintain raw data, and produce accurate laboratory records.
- Communicates and works well with others, able to represent the department in meetings and on project teams.
- thirty
About the Company:
This is an exciting opportunity to join a major BioPharma company manufacturing large scale monoclonal antibody biologic therapeutics and vaccines including a vaccine for COVID-19.
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