As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is strongly desired.
Essential Functions and Responsibilities
- Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot Iovance s GMP cell therapy manufacturing process(es).
- Complete training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented.
- 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.
- Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that may include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday, Thursday to Sunday, etc). May be required to work overtime.
- 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.