Cell Therapy Specialist

ACL Digital; Frederick (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

ACL Digital is seeking a highly motivated Cell Therapy Specialist I to join our new Cell Therapy Manufacturing team in Frederick, MD. The role involves manufacturing commercial products following batch records and SOPs to ensure safe, compliant operations in GMP environments.

The position requires an Associate degree in Life Sciences or a high school diploma with cGMP experience, and may involve varied shifts (days/evenings).

Qualifications

• Troubleshoots processing and equipment issues; communicates findings to management.
• Completes required training to maintain technical skills and cGMP compliance.
• Authors or revises SOPs to align with cGMP requirements.

Responsibilities

• Troubleshoots processing and equipment issues and reports to management.
• Completes required training to maintain technical skills and cGMP compliance.
• Creates or revises SOPs for clear, compliant instructions.
• Operates automated cell processing, expansion and filling equipment in Grade B/C clean rooms with PPE.
• Identifies opportunities to improve manufacturing efficiency and compliance; supports investigations and change controls.
• Wear a respirator when using certain cleaning chemicals.

Skills

Troubleshooting

SOP creation/revision

cGMP compliance

Equipment operation

Education

Associate degree in Life Sciences

High School Diploma with 2+ years cGMP experience

Job description

Job Title: Cell Therapy Specialist I (Contract)

IMPORTANT: For the first 8-10 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing Onboarding Technical Training. After the training is successfully completed, the contractor is deployed onto the shift as needed by the department leadership. During the Technical Training period, employees will observe the Client Holiday Schedule. Once deployed to shift, employees will be considered "essential" and will work their respective shifts during company holidays/shutdowns.

Role is full-time 4/10 role, however 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, Wed-Sat, and Thurs-Sun

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

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

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.

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

Responsibilities (include but are not limited to):

To be considered for this role, you must meet the following basic criteria:

• 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:

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