Cell Therapy Specialist I
4 giorni fa
Job Location: Frederick MD
Role is fully Onsite 5 days a week.
Job Duration: 6 months Description:
IMPORTANT: For the first 7 weeks of the assignment all contractors are required to work MonFri () to complete New Hire Orientation and Manufacturing Onboarding Technical Training.
After the 7 weeks the contractor is deployed onto their agreed upon shift. Role is full time 4/10 role but the roles and shifts can change with the needs of the dept.
Shift times will be directed by the manager or dept leads. 6:00 am to 4:30 pm (Day Shift) SunWed and WedSat
3:00 pm to 1:30 am (Swing Shift) SunWed and WedSat 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.
Do you have a background in cGMP manufacturing If the answer is yes wed like to consider you 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
o 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 Requirements:
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
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