Senior Aseptic Manufacturing Technician
1 week ago
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.
- 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.
- 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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Senior Aseptic Manufacturing Technician
4 weeks ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Aseptic Manufacturing Technician to join our team at Iovance Biotherapeutics, Inc. As a key member of our autologous cell therapy manufacturing program, you will be responsible for ensuring the quality and integrity of our products.Key ResponsibilitiesDevelop and execute aseptic...
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Senior Aseptic Manufacturing Technician
2 weeks ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full timeJob Title: Senior Aseptic Manufacturing TechnicianJob Summary:Iovance Biotherapeutics, Inc. is seeking a highly skilled Senior Aseptic Manufacturing Technician to join our team. As a key member of our autologous cell therapy manufacturing program, you will be responsible for developing a subject matter expert-level understanding of our GMP cell therapy...
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Lead Aseptic Manufacturing Technician
4 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob SummaryThe Lead Aseptic Manufacturing Technician is responsible for providing guidance and leadership to the Aseptic Manufacturing Technicians' teams. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.Key ResponsibilitiesDevelop a Subject Matter Expert (SME)-level understanding of and...
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Aseptic Manufacturing Lead
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Philadelphia, Pennsylvania, United States R&D Partners Full timeJob Title: Aseptic Manufacturing LeadThe Aseptic Manufacturing Lead plays a crucial role in providing guidance and leadership to the Aseptic Manufacturing Technicians' teams. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes.Key Responsibilities:Develop a Subject Matter Expert (SME)-level...
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Senior Aseptic Manufacturing Specialist
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Philadelphia, Pennsylvania, United States R&D Partners Full timeJob SummaryWe are seeking a highly skilled Senior Aseptic Manufacturing Specialist to join our team at R&D Partners. The ideal candidate will have a strong background in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.Key Responsibilities:Develop a deep understanding of GMP cell...
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Philadelphia, Pennsylvania, United States Planet Pharma Full timeJob SummaryWe are seeking a highly skilled Aseptic Manufacturing Technician to join our team at Planet Pharma. As a key member of our manufacturing operations team, you will be responsible for ensuring the quality and integrity of our cell therapy products.Key ResponsibilitiesDevelop a comprehensive understanding of our cell therapy manufacturing process and...
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Aseptic Manufacturing Specialist
3 weeks ago
Philadelphia, Pennsylvania, United States Planet Pharma Full timeJob SummaryWe are seeking a highly skilled Aseptic Manufacturing Technician to join our team at Planet Pharma. As a key member of our manufacturing operations team, you will be responsible for ensuring the quality and integrity of our cell therapy products.Key ResponsibilitiesDevelop a comprehensive understanding of our current cell therapy manufacturing...