The QC Analyst/Sr. QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
1. Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
2. Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
3. Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
4. Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
5. Perform peer review/approval of laboratory data.
6. Utilize electronic systems (LIMS) for execution and documentation of testing.
7. Create, review and approve relevant QC documents, SOP’s and WI’s.
8. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
9. Other duties will be assigned, as necessary.
Key Relationships Works in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development.
Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
Experience: A Minimum of 2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
Key Capabilities, Knowledge, and Skills: