Manufacturing Associate – Cell Therapy

Manufacturing Associate – Cell Therapy

Requirements

• 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.
• High school diploma and 0-2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.

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 regiment as required to meet global Health Authority requirements.

Preferred Qualifications

• Bachelors in relevant science or engineering discipline is preferred.