Senior Cell Therapy Technician

Philadelphia Metro Area, PA

Job Type: Scientific Job Number: JN -052024-32499 Region: Philadelphia Metro Area

Job Description

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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