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 (Day/Night)

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.

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