Elevatebio

Elevatebio

Biomanufacturing Associate II (Contract, Multiple Openings)

Waltham, Massachusetts, United States · Mid

Sponsorship not specifiedDetected 8 days ago
TypeScriptExcelGMPCRISPRCell CultureLeadershipCommunicationMicrosoft Office

About the role

  • Provide training to team on set-up and use of equipment, process and material flows, as assigned.
  • Ensure clean rooms are maintained in an organized and ready state.
  • Provide constructive input on teams for the selection and set-up of equipment, process and material flows, etc.

Responsibilities

  • Perform and lead routine right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection.
  • Perform manufacturing/operations start-up activities including but not limited to authoring SOPs, batch records, reports, risk assessments, material ordering/management.
  • Create and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products.
  • Generate and manage batch records, run reports, batch data, etc. for manufacturing and scale-up activities.

Requirements

  • Bachelor's degree in biological science(s) field or related engineering with:
  • Experience with some or all of the following: cGMP manufacture and/or process development for CAR T, TCR, NK, cellular therapies, AAV, LV, RV.

Nice to have

  • 2+ years of experience in project leadership is preferred.
  • Outstanding communication skills (verbal and written)
  • Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word.
  • Demonstrate proficiency in aseptic technique and/or processing.
  • Ability to function in dynamic environment and balance multiple priorities simultaneously.
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