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Cell Therapy Manufacturing Specialist
2 months ago
LanceSoft, Inc. is seeking a highly motivated Cell Therapy Manufacturing Specialist to join our newly formed Cell Therapy Manufacturing team at our brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland.
About the RoleThe Cell Therapy Manufacturing Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.
Responsibilities- Successfully troubleshoots processing and equipment issues while communicating said issues to management.
- Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements.
- Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operations.
- Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms all required PPE and gowning for classified GMP manufacturing areas is provided by the company.
- Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls.
- BA / BS Degree in Sciences Field OR AA Degree with 1+ years of cGMP experience OR High School Degree and 2+ years of cGMP experience.
Why LanceSoft, Inc.? We are a company leading the way in developing and producing unique, innovative immunotherapies. Our team is passionate about making an impact on people's lives and we are excited to have you join us in this mission.
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