Manufacturing Specialist - 2nd Shift

ACL Digital; Frederick (MD); On-site; USD 30,000 - 39,000; Full time

Job summary

ACL Digital seeks a Cell Therapy Technician to join the new Cell Therapy Manufacturing team in Frederick, Maryland. The role involves following batch records and SOPs to manufacture commercial products in a state-of-the-art facility.

You will operate and troubleshoot automated cell processing equipment within Grade B/C clean rooms, with PPE provided. Training and compliance with cGMP are expected as part of a collaborative team effort.

Qualifications

• 1+ years related experience with High School Diploma.
• Background in cGMP manufacturing and SOP adherence.
• Ability to follow batch records and operate GMP equipment.

Responsibilities

• Verify and perform tasks per batch records and SOPs in GMP runs.
• Monitor, clean, prepare and operate cell processing equipment in clean rooms.
• Assist with investigations, deviations and change controls for improvements.
• Wear PPE and respirator when required in clean room environment.

Skills

cGMP manufacturing

Troubleshooting

Communication

Education

High School Diploma

Tools

Automated cell processing equipment

Job description

Manufacturing Associate

Duration: 12+Months

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

Everyone at this facility is grounded by one common goal – curing cancer. We are seeking a highly motivated, Cell Therapy Technician 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 Technician 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.

Do you have a background in cGMP manufacturing? 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
• 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

1+ years related experience with High School Diploma