Manufacturing Associate l

Job Title:

Manufacturing Associate l

Job Duration: 6 Months with potential to extend

Job Location:

Devens, MA

Reports To:

Manager, Cell Therapy Manufacturing

Shift

Schedule:

After completing training
- Wednesday
- Saturday | 7 AM - 5 PM

• Week 1:
  Monday through Friday, 8:00 a.m.
  
  - 4:00 p.m.
• Beginning Week 2 (4-8+ weeks):
  Tuesday
  - Friday, 9:00 a.m.
  
  - 7:00 p.m.

Looking for an Associates within Manufacturing that bring enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.

• Perform patient process unit operations and support operations described in standard operating procedures and batch records.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Complete training assignments to ensure the necessary technical skills and knowledge.
• Assist in setting up manufacturing areas and equipment/fixtures.
• Perform facility and equipment commissioning activities.
• Train others on SOPs and Work Instructions to successfully complete manufacturing operations.
• Execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regimen as required to meet global Health Authority requirements.

• High school diploma and 0-2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
• Bachelor's in a relevant science or engineering discipline is preferred.

• Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
• Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing.
• Must be comfortable being exposed to human blood components.
• Must be able to be in close proximity to strong magnets.

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.

• Stand and Walk: Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
• Carrying weight, Pushing, Pulling, Lifting: Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
• Climb: Required to climb (use of stepladders in production areas, or stairwells) several times a day.
• Bend and Kneel: Required to bend or kneel several times a day.
• Overhead Work: Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
• Moving Head and Neck: Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
• Twisting: Required movement of twisting waist while setting up equipment several times a day, throughout the day.
• Repetitive Use: Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day, throughout the day.
• PPE Requirement: Will be required to wear personal protective equipment (PPE) and other cleanroom garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.