Laboratory Technician

Job Description

Job Title: Manufacturing Associate I - Cell Therapy

Job Duration: 6 Months with potential to extend

Job Location: Devens, MA

Shift Schedule:

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

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• Performing patient process unit operations and support operations described in standard operating procedures and batch records.
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• 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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• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
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• Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
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• Completing training assignments to ensure the necessary technical skills and knowledge.
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• Assisting in setting up manufacturing areas and equipment/fixtures.
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• Perform facility and equipment commissioning activities.
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• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
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• Executing daily unit operations schedule that includes people, product, and material flow across multiple shifts.
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REQUIRED COMPETENCIES

Education:

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• Bachelor’s in a relevant science or engineering discipline is preferred.
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• High school diploma and 2 years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
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Preferred Qualifications:

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• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
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Applicant Notices & Disclaimers:

For information on benefits, equal opportunity employment, and location-specific applicant notices, click here.

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.