Cell Therapy Specialist I
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Job Detail
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Job Description
Job Description
We are seeking a highly motivated, Cell Therapy 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.
The Cell Therapy 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 of the Cell Therapy Specialist include:
• 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 of 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
Basic Qualifications:
- Associate and 1+ years of biomanufacturing experience OR
- High School Diploma/GED and 2+ years of biomanufacturing experience
Preferred Qualifications:
- GMP experience
- investigations/deviations and change controls