Process Development Associate III, Cell Processing

Job ID
9547
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
US-WA-Seattle
Category
Manufacturing

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.   

 

As a Process Development Associate III, the position acts both independently and as a team collaborator within the lab to lead multiple laboratory projects including but not limited to: isolation, enrichment, transduction and expansion of novel B-cell/T-cell/stem cell platforms, complex analytical procedures, data compilation/interpretation, and generating detailed technical reports/presentations. In addition, this position helps identify emerging technologies and automation, monitors industry trends and conducts evaluations for feasibility. This position works with and under the guidance of Process Development management for experimental design, study execution, data analysis and data interpretation. PD Associates also interact heavily with internal and external research and principal investigator labs, GMP manufacturing, Quality Control, Quality Assurance, and other scientific/administrative staff, as needed.

Responsibilities

The position focuses on the development, optimization, and transfer of cellular and gene therapy unit operations including cell selections from starting materials, genetic modifications (viral transduction, electroporation, etc.), growth/expansion conditions, media/cytokine formulations, cell harvests, cryopreservation, and freeze-thaw recovery. In addition, this position collaborates to develop robust and repeatable analytical methods to characterize starting, in-process and final, formulated cellular products. Ultimately, development activities generate robust, repeatable and scalable processes to support toxicology studies, technology transfer/product introduction into the Fred Hutch GMP Cell Processing manufacturing facility, and IND generation to enable clinical trial initiation. 

Qualifications

  • BS/MS in a biological sciences discipline, and 10+ years (BS) or 7+ years (MS) experience in Process Development, or equivalent combination of education and experience.
  • Direct experience in a Process Development environment supporting aseptic cell culture based manufacturing operations including 2+ years hands-on experience with B-cell/T-cell/stem cell isolation and expansion protocols.
  • Experience in one or more of the following technical areas:
    • Adherent and/or suspension cell cultures in flasks and/or bioreactors (fed-batch, perfusion, disposable bioreactor systems, etc.).
    • Cell culture media development and optimization.
    • Associated upstream and downstream unit operations such as cell banking, virus removal, purification, etc.
    • Cryopreservation and recovery of cryopreserved cells.
  • Preferred Experience: extensive demonstrated aseptic processing/cell culture experience; successful demonstration of process/technology transfer, trouble-shooting issues associated with process scale-up, transfer into a GMP manufacturing setting, and generating process transfer documentation.

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