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Cell Therapy Specialist
3 months ago
Responsibilities:
- Excellent employment opportunity for a Cell Therapy Specialist in the Frederick, MD area. (onsite)
- 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.
- IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Monday to Friday, (0830-1700) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After 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 department. Shift times will be directed by the Manager or Department Leads.
- 6:00 am to 4:30 pm (Day Shift), Sunday-Wednesday and Wednesday-Saturday
- 3:00 pm to 1:30 am (Swing Shift), Sunday-Wednesday and Wednesday-Saturday
- 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.
- 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 controlsExperience:
- 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
**Job Type**: Contract
Schedule:
- 8 hour shift
- Day shift
**Education**:
- Bachelor's (required)
**Experience**:
- Manufacturing: 3 years (required)
Work Location: In person
