Cell Therapy Specialist

Description

Do you have a background in cGMP manufacturing? If the answer is yes, we’d like to consider you!

IMPORTANT: For the first 6-8 weeks of the assignment, all contractors are required to work Mon-Fri (07:30-16:00) to complete New Hire Orientation and Manufacturing On-boarding Technical Training.

After the training is successfully completed, the contractor is deployed onto the shift as needed by the dept leadership.

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), Sun-Wed and Wed-Sat

3:00 pm to 1:30 am (Swing Shift), Sun-Wed and Wed-Sat

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.
• Are you passionate about making an impact on people’s lives? Would you be excited to work for a company leading the way in developing and producing unique, innovative immunotherapies? 

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
• 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