Cell Therapy Specialist

4 weeks ago


Baltimore, United States American Society Of Gene & Cell Therapy Full time

Job Title : Cell Therapy Specialist IDuration : 12 MonthsLocation : Frederick, MD 21701Shift Timings:6:00 am to 4:30 pm (Day Shift), Sun-Wed and Wed-Sat3:00 pm to 1:30 am (Swing Shift), Sun-Wed and Wed-SatJob Description: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 managementCompletes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirementsAuthors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements and supports efficient operationsRoutinely 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 controlsBasic Requirements:BA / BS Degree in Sciences FieldAA Degree with 1+ years of cGMP experienceHigh School Degree and 2+ years of cGMP experience#J-18808-Ljbffr

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