Job Description
Job Title : Manufacturing Associate I - Cell Therapy
Job Duration : 6 Months with potential to extend
Job Location : Devens, MA
Shift Schedule : (There will be 6-8 weeks of training 7 AM – 4 PM, Monday to Friday)
Rotational shift schedule
PURPOSE AND SCOPE OF POSITION
The client seeks Associates within manufacturing who 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.
- 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.
- 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.
REQUIRED COMPETENCIES
Education :
Bachelor’s in a relevant science or engineering discipline is preferred.High school diploma and 2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.Preferred Qualifications :
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.