Cell Therapy Manufacturing Supervisor

6 hours ago

Watertown, Massachusetts, United States ElevateBio Full time
Cell and Gene Therapy Manufacturing Supervisor

ElevateBio is a technology-driven company that accelerates access to cutting-edge cell and gene therapy technologies. Our integrated model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

We are seeking a dynamic individual to join our manufacturing operations team at our BaseCamp facility. The successful candidate will supervise routine cGMP manufacture of multiple cell and gene therapy types/products, including autologous/allogenic cell therapies and other advanced therapies.

Key Responsibilities:
  • Lead right-first-time cGMP manufacturing of cell and gene therapy products, including aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish, and final product visual inspection.
  • Lead manufacturing/operations tech transfer activities, including authoring SOPs, batch records, reports, risk assessments, material ordering/management.
  • Provide constructive input on teams for the selection and set-up of equipment, process, and material flows.
  • Create and maintain training materials and curricula that support continuous improvement in the cGMP manufacture of cell therapy products.
  • Work effectively with cross-functional teams to ensure right-first-time technology transfer.
  • Proactively resolve issues such as deviations, CAPAs, and Change Controls.
  • Commitment to the highest safety and quality standards in service of our colleagues and patients.
  • Generate and manage batch records, run reports, batch data, etc. for manufacturing and scale-up activities.
  • Proactively identify opportunities for improvements in process, safety, quality, and cost.
  • Be integral in providing hands-on technical, organizational, and leadership expertise to the manufacturing department.
  • Ensure the safety of assigned areas and work practices in accordance with EHS program.
Requirements:
  • Bachelor's degree in biological science(s) field or related engineering with 4-6 years of experience in cGMP biotech manufacturing, preferably cell and gene therapies.
  • 2+ years of experience in people leading and/or project leadership.
  • Experience with some or all of the following: cGMP manufacture and/or process development for CAR T, TCR, NK, cellular therapies, AAV, LV, RV, or other biologics.
  • Advanced understanding of primary cell culture and experience with equipment such as CliniMACS Plus, CliniMACS Prodigy, LOVO, bioreactors (single-use and fixed-bed), chromatography skids, TFF (hollow-fiber and flat-sheet), and WAVE bioreactors.
  • 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 a dynamic environment and balance multiple priorities simultaneously.
Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. We commercialize our enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission: To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision: We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created, and how disease is treated.

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