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 maintain... more details
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.
Support interdepartmental projects in a contributor capacity.
Supports technical transfer and additional research level testing activities, as needed.
Preferred Qualifications
Minimum 2+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
May require up to 5% travel, based on business need.
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