Sr/Scientist, Cell Therapy & Gene Editing, Process Development

King of Prussia

Summary

This role is responsible for planning, executing, analyzing, reporting on, and presenting on studies related to gene editing and cell therapy process development. This position works closely with the Cell Therapy Process Development leader, and the client to understand, discuss, and deliver against defined objectives. This role authors and reviews technical protocols and reports, and procedures. The ideal candidate should have a track record of demonstrated success as well as personal attributes including initiative, independent thinking, solution-oriented, and collaboration skills.

Responsibilities

  • Independent functioning as a bench scientist, capable of planning, executing, analyzing and reporting on studies related to gene editing and cell therapy process development.
  • Independent manager of work, including sourcing of materials, use of equipment and space, time management, problem solving, and risk identification/escalation to meet objectives.
  • Strong team member and contributor to overall cell therapy process characterization, development and validation activities individually or in a team
  • Design and validate novel strategies for autologous or allogeneic cell therapy platforms.
  • Capability to be hands-on in laboratory work in developing, executing, and optimizing of cell therapy unit operations
  • Authors, and reviews process development study protocols, reports, and batch records
  • Collaborates with Analytical Development to meet testing needs
  • Works closely with clients and technical team on appropriate process and characterization studies to enable manufacturing
  • Leads product quality attribute assessment and scoring to identify critical quality attributes (CQA)

Qualifications

  • BS (5+ years’ experience), MS (3+), or PhD in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic cell therapy (iPSC, NK or T-cells) technologies and demonstrated laboratory proficiency
  • Extensive hands-on experience on gene editing technologies (CRISPR etc.) in human iPSC, NK, or T-cells and selection of edited clones & their characterization is required
  • Knowledge and experience in stem cells (iPSCs or MSCs) reprogramming, culture and differentiation into various cell types
  • Hands-on experience with most equipment and unit operations of cell therapy process development is highly preferred.
  • Expertise in operating cell culture bioreactors at development or pilot scale is plus.
  • Thrives in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Able to communicate project status, risks, needs, and data/information and its practical application to junior staff and management
  • Flexible for occasional weekend work

Education & Experience

BS (5+ years’ experience), MS (3+), or PhD in molecular biology, immunology, Cancer Biology, or similar life sciences degree with expertise in allogeneic cell therapy (iPSC, NK or T-cells) technologies and demonstrated laboratory proficiency

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