Cell Therapy Specialist I*

Job Title: Cell Therapy Specialist I*

Location: Frederick, Maryland, 21704

Duration: 6 Months contract-possible to extend

Shift Details: 1^st shift

Pay Range : $30/h to $34/h -on basis of experience

Job Description:

For the first 6-8 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) 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
Everyone at this facility is grounded by one common goal curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?

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
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