Cell Therapy Manufacturing Specialist
6 days ago
We are seeking a highly skilled Manufacturing Engineer I to join our team at CARsgen Therapeutics. As a key member of our manufacturing team, you will be responsible for the manufacture of cellular drug therapies within a GMP setting.
Key Responsibilities- Execute batch records in compliance with current regulations and quality standards for the manufacture of CAR-T cell therapy products.
- Participate in the lifecycle of manufacturing from preparation to support of product release.
- Work collaboratively with Quality, MSAT, Supply Chain, EHS, and Facilities to ensure safe and effective manufacturing of patient products.
- Perform data entry and accurate calculations to determine cell concentration, cell viability, and dilutions.
- Prepare and maintain cell culture reagents and media, and perform verification steps to ensure batch record errors and deviations are addressed and resolved.
- Apply aseptic techniques and ensure proper operation and performance of manufacturing equipment.
- Contribute to documentation and investigation of non-conformance, deviations, and CAPAs.
- Bachelor's degree in a related scientific or engineering discipline with 5+ years' experience in GMP manufacturing operations or 3+ years' experience with a Master's degree or 0+ years' experience with a Terminal degree.
- Experience with cell culture, cryopreservation, purification, filling, and aseptic processing, CAR-T manufacturing is a plus.
- Ability to read and adhere to SOPs and current Good Manufacturing Practices to ensure quality of product.
- Ability to gown appropriately for cleanroom manufacturing.
- Understanding of cGMP documentation and practices.
- Highly ethical and transparent with professional sensitivity and care with confidentiality.
- Strong communication, written and verbal, and strong organizational and time management skills.
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Cell Therapy Manufacturing Specialist
6 days ago
Durham, North Carolina, United States CARsgen Therapeutics Full timeJob SummaryWe are seeking a highly skilled Manufacturing Engineer I to join our team at CARsgen Therapeutics. As a key member of our manufacturing team, you will be responsible for the manufacture of cellular drug therapies within a GMP setting for ongoing product pipelines.Key ResponsibilitiesExecute batch records in compliance with current regulations and...
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