Manufacturing Specialist

Title: Cell Therapy Specialist I

Location: Frederick, MD

Job Duration: 6+ Months

Schedule & Training

• First 8–10 weeks: Monday–Friday, 7:30 AM–4:00 PM for New Hire Orientation and Manufacturing Technical Training.
• After training, employees are assigned to department shifts based on business needs.
• During training, employees follow the company holiday schedule.
• Once deployed to shift, employees are considered essential personnel and may work during holidays and company shutdowns.

Potential Shift Schedules (4x10s):

• Day Shift: 6:00 AM–4:30 PM (Sun–Wed, Wed–Sat, or Thu–Sun)
• Swing Shift: 3:00 PM–1:30 AM (Sun–Wed, Wed–Sat, or Thu–Sun)
• Swing Shift: 5:00 PM–3:30 AM (Sun–Wed, Wed–Sat, or Thu–Sun)

Shift assignments and schedules may change based on departmental needs.

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