Associate Director / Director, Process Development

The position represents an excellent opportunity for career development in a fast-paced and highly collaborative environment. The successful candidate will be expected to play an integral role in the development and translation of the TRuCTM T cell platform. Specifically, the successful candidate will drive innovation of lentiviral and T cell manufacturing, whilst supporting protein, in vitro and in vivo immunology teams. The candidate will be expected to develop and manage a cutting-edge team that will catalyze the growth of the TCR2 platform.

Responsibilities:

  • Manage lentiviral process development for pre-clinical candidates and optimize manufacturing processes for both in-house and tech transfer needs
  • Lead process development strategy and execution for gene-edited ex-vivo cell therapy products based on TRuCTM T cells for rapid transition of early-stage candidates into the clinic
  • Partner closely with the research team to guide process development processes to ensure a streamlined and feasible product development transition
  • Manage technology transfer strategy, protocol development and establish acceptance specifications for transition to CMO GMP facility for all CMC activities with ability to travel for in-person and in-plant interactions
  • Define and build an effective organization to oversee process development/transfer and in-house manufacturing oversight through personal leadership, and direct reports
  • Assemble technical content for IND submissions for first-in-human clinical trials
  • Collaborate with other departments to identify efficiencies needed to meet critical corporate objectives, encompassing the area of viral vector and engineered T cell manufacturing
  • Influence through effective communication, respectful challenge, and persuasion across the research organization

Requirements:

  • Ph.D. in Cell Biology, Immunology or Virology is required
  • A minimum of 8-10 years post-graduate experience in an academic or, preferably, an industrial setting
  • Proven track record in leading pre-clinical stage programs and cross-functional teams is required
  • Biotech experience is strongly preferred with a focus on cell and gene therapy, virology or biologics
  • Previous experience with development and manufacture of viral vectors and engineered T cells is strongly preferred
  • Ability to adapt and thrive in a dynamic and entrepreneurial early-stage environment
  • Superior personnel management and organizational skills
  • A scientifically motivated self-starter, capable of independently conceiving, conducting, and critically analyzing his/her own work with minimal supervision
  • A strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment

Interested candidates should send their resume to careers@tcr2.com