Manufacturing Specialist

Title: Cell Therapy Specialist I

Location: Frederick, MD

Job Duration: 6+ Months

Shift:

For the first 6-8 weeks of the assignment, all contractors are required to work Mon-Fri (07:30 am-4:00 pm ) 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

5:00 pm to 3:30 am (Graveyard Shift), Sun-Wed, Wed-Sat, and Thurs-Sun

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.

Responsibilities (include but are not limited to):

• 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 are provided by the company.
• Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls
• Ability to wear a respirator during use of certain cleaning chemicals

Basic Qualifications:

• Bachelor’s Degree in Life Sciences Field
• Associates Degree in Life Sciences Field with 1+ years of biotech experience or
• High School Diploma with 2+ years of cGMP experience