Senior Aseptic Manufacturing Technician

1 week ago


Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time
Job Summary

Iovance Biotherapeutics, Inc. is seeking a highly skilled Aseptic Manufacturing Technician to join our team in the development and commercialization of novel cancer immunotherapies. As a key member of our autologous cell therapy manufacturing program, you will be responsible for executing and troubleshooting our GMP cell therapy manufacturing process.

Key Responsibilities
  • Develop a Subject Matter Expert (SME)-level understanding of our GMP cell therapy manufacturing process and execute it with precision.
  • Complete training sessions and maintain accurate training documentation.
  • 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, which may include weekends, evenings, and holidays.
  • Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
  • Execute documentation Change Controls of SOPs, Batch records, etc. as needed.
  • Support interdepartmental projects in a contributor capacity.
  • Perform basic revisions as needed to accurately reflect current procedures.
Requirements
  • Bachelor's degree or some post-secondary education or equivalent experience.
  • Demonstrated technical knowledge of aseptic processing in cleanroom environments.
  • Ability to mentor and provide best practices to new technicians.
  • Must be able to read, write, and understand English, especially for Good Documentation Practices.
  • Ability to accurately and reproducibly perform arithmetic calculations.
  • Ability to build relationships quickly and credibly.
  • Ability to work successfully in a fast-paced team-oriented environment.
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.
  • 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.


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