Essential Functions and Responsibilities
- Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot GMP cell therapy manufacturing process(es).
- Provide operational support functions including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Perform document review, including executed Batch Records and Logbooks.
- Support documentation needs, which may include drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
- Execute documentation Change Controls of SOPs, Batch records, etc. as needed.
Preferred Qualifications
- Minimum 2+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.