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Lead Manufacturing Associate
Cell Therapy
Posted on 7/19/2022
INACTIVE
Locations
Devens, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Leadership
Writing
Requirements
  • 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
  • Bachelors in relevant science or engineering discipline, or equivalent in work experience
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
  • 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
Responsibilities
  • Execute operations described in standard operating procedures and batch records
  • Demonstrates strong practical and theoretical knowledge in their work
  • Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
  • Solves complex problems; takes new perspectives using existing solutions
  • Performs 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
  • Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities
  • Collaborates with support groups on recommendations and solving technical problems
  • Help to ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule
  • Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status
  • Supports investigations
  • Identifies innovative solutions
  • Supports writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
  • Training others on SOPs, Work Instructions to successfully complete manufacturing operations
  • Working with production planning with leadership to execute 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
Desired Qualifications
  • Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment
  • Experience in the following preferred: Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas
  • Cell expansion using incubators and single use bioreactors
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.