Job Title: Manufacturing Associate I (Cell-Therapy Biomanufacturing)
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 AM - 4 PM, Monday to Friday)
Shift:
Morning Shift: 6 AM to 6 PM (Panama Schedule)
Night Shift: 6 PM to 6 AM (Panama Schedule)
PURPOSE AND SCOPE OF POSITION
Client Cell Therapy Manufacturing seeks 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.
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.
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.