Senior Scientist, Cell Therapy CMC Analytical Development

Research & Development Cambridge, Massachusetts


Description

About Us:
We are Repertoire Immune Medicines – a Flagship Pioneering company working to unleash the remarkable power of the human immune system. We seek to harness the intrinsic ability of T cells to prevent and cure disease. Our mission is a challenging one, requiring a complex and multi-dimensional approach that integrates cutting-edge biology and sophisticated, novel technologies. We stand ready to meet this challenge with our unique platforms, world-class team and unparalleled network of researchers, clinicians, academics and entrepreneurs.

Position overview:
We are seeking a highly motivated analytical development professional to join the rapidly growing Cell Therapy Analytical Development/Quality Control group.  As part of the CMC Analytical Development team, you will contribute to advancing Repertoire’s DEPLOY platform: multi-antigen, cytokine-enhanced T Cell Therapies.  The DEPLOY platform is a novel class of adoptive T cell therapies comprising endogenous multi-antigen T cells and engineered immune modulators.  This will be a high visibility role in the Technical Operations organization, with cross-functional impact on the Research & Development and Translational Science groups.

This is an opportunity to develop strategy and methods for functional use tests of highly complex, critical raw materials in a product development setting with aspects of immune-oncology, protein biologics and T cell therapy.  There also will be collaborative efforts with immunologists, quality control professionals, bioengineers, translational scientists and process engineers to develop next-generation potency assays.  Ultimately, this role will increase understanding of our Drug Substance/Drug Product processes, process intermediates and final products, enabling us to reproducibly release safe, efficacious Drug Product for use in clinical trials that improve patient lives.  The successful candidate will be an expert using both molecular biology and immune-oncology tools like flow cytometry, reporter assays, immunoassays, and cell-based (functional) assays to characterize complex samples and generate actionable data.  Primary responsibilities include analytical lifecycle strategy, experimental design and execution, data analysis, documentation, and verbal and written communication of results to the team, management and external partners.

The ideal candidate will have demonstrated experience with complex experimental design and execution with a high level of scientific rigor both independently and in team settings.  They will have a self-starting attitude and the ability to focus and execute in a fast-paced, dynamic, and highly collaborative environment.  They will be comfortable leading projects in a matrix environment.  Strong interpersonal, verbal and written communication skills are essential in our ultra-collaborative work environment.  There is significant opportunity for career growth and continuous learning in the highly collaborative Repertoire work environment.

Responsibilities:

  • Develop analytical lifecycle strategy for critical raw materials testing and potency methods
  • Develop novel assays for the characterization of critical raw materials such as cytokines, sera, media supplements and peptides
  • Collaborate with Research & Discovery groups to develop next-generation potency assays that improve Repertoire’s understanding of antigen-reactive T cells
  • Lead from the bench, with ownership over experimental design, analysis, documentation, and supervision of junior staff
  • Design method qualification strategies and assist with method transfers to external CDMOs
  • Project leadership and technical support for external testing laboratories and CROs

 

Qualifications:

  • S./Ph.D. in a relevant scientific discipline (Bioengineering, Cell Biology/Immunology, Molecular Biology, Biochemistry, etc.) with 4+ years relevant industry experience
  • Demonstrated ability to develop and optimize analytical methods for the characterization of biologics and T cell therapies
  • Experience working with cell therapies in the biotech/pharma industry is highly preferred
  • In-depth knowledge and hands-on experience with analytical techniques such as multi-color flow cytometry, multiplexed immunoassays and cell-based assays.
  • Demonstrated ability to design and execute complex functional assays
  • Demonstrated curiosity and ability to master new scientific disciplines and troubleshoot both technical and scientific problems
  • Ability to lead by example in the laboratory setting with safe lab practices, aseptic techniques and thorough documentation using ELN
  • Strong interpersonal skills including verbal and written communication skills are essential in our ultra-collaborative work environment
  • Previous experience managing a group and/or external projects is a plus