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: (There will be 6-8 weeks of training, 7-4 pm M-F) 
After completing training - 6 AM to 6 PM | Alternating Wednesday and Thursday - Saturday.
 

PURPOSE AND SCOPE OF POSITION

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.

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DUTIES AND RESPONSIBILITIES

• Performing patient process unit operations and support operations described in standard operating procedures and batch records.

• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.

• Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.

• Completing training assignments to ensure the necessary technical skills and knowledge.

• Assisting in setting up manufacturing areas and equipment/fixtures.

• Perform facility and equipment commissioning activities.

• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.

• Executing 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.

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REQUIRED COMPETENCIES

Education:

• 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.

Experience:

• 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.

Preferred Qualifications:

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

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PHYSICAL DEMANDS

• 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.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $27.00/hr.