Position Summary:
Manufacturing Engineer I performs the manufacture of cellular drug therapies within a GMP setting for ongoing product pipelines. Operates under current regulations and company policies. Participates in the lifecycle of manufacturing from preparation to support of product release.
Responsibilities:
- Manufacture of CAR-T cell therapy products by executing batch records in compliance with current regulations and quality standards.
- Perform Manufacturing new hire training and assessments.
- Operate cell manufacturing equipment and instrumentation as part of batch record execution.
- Work both independently and cross-functionally with Quality, MSAT, Supply Chain, EHS and Facilities to ensure safe and effective manufacturing of patient's products.
- Perform data entry and accurate calculations to determine cell concentration, cell viability and dilutions.
- Routine preparation and maintenance of cell culture reagents and media.
- Perform verification steps assuring any batch record errors and or deviations are addressed and resolved.
- Meticulous attention to detail and high level of accuracy in lab work and documentation.
- Application of aseptic techniques.
- Ensure proper operation and performance of manufacturing equipment and accurately complete equipment logbooks.
- As required, participate in the manufacturing equipment cleaning program and work to assure all critical environments are maintained per qualified methods.
- Contribute to documentation and investigation of non-conformance, deviations, and CAPAs.
Qualifications:
- Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.
- Bachelor's degree in a related scientific or engineering discipline with 5+ years' experience related GMP manufacturing operations or 3+ years' experience in related GMP manufacturing operations with Master's degree or 0+ years' experience in related GMP manufacturing operations with Terminal degree.
- Experience with cell culture, cryopreservation, purification, filling and aseptic processing, CAR-T manufacturing a plus.
- Experience with cell processing and manufacturing equipment such as bioreactors, cell counters, incubators, centrifuges, Biological Safety Cabinets, pipettes and other common cleanroom equipment.
- 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.
- Ability to perform physical tasks requiring dexterity and mobility. Daily tasks call for routine walking, standing in cleanroom environments and occasional lifting of heavy materials.