Associate Director/Principal Scientist, Group Lead CMC Analytical Development (Cell Therapy)

Tech Ops Cambridge, Massachusetts


Description

Company Overview

Repertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease.  The company is founded on the belief that the repertoire of T cell receptor (TCR)-antigen codes that drive health and disease represents one of the greatest opportunities for innovation in medical science.  Repertoire scientists created and developed the DECODE and DEPLOY suite of technologies, which allow in-depth characterization of TCR-antigen pairs, and the ability to rationally design and develop novel targeted immune medicines.

From its sites in Cambridge, Mass., and Zurich, Switzerland, Repertoire’s team of more than 120 is creating a new category of immune medicines enabled from its DECODE discovery platform.  The company’s first product in the clinic is a novel multiclonal T cell therapy consisting of T cells derived from the peripheral blood, activated against a curated set of antigens, and armed with a proprietary cytokine.  Repertoire is in clinical-stage immuno-oncology development today, targeting metastatic solid tumors.  In the field of autoimmunity, Repertoire is using its proprietary platform to discover novel epitopes and TCRs from patients with type 1 diabetes.  The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.

Role Overview

We are seeking an experienced CMC analytical development professional with cell and gene therapy industry experience.  This person will be responsible for leading the CMC Analytical Development efforts in the rapidly growing Analytical Development/Quality Control team within our Technical Operations (CMC) department.  The successful candidate will work closely in a cross-functional team of immunologists, cell biologists, analytical chemists, process engineers, and product development professionals to formulate CMC analytical strategies for cell therapy and biologics-based modalities.  This will be an exciting role focused on developing potency assays, raw material testing and controls, QC-viable analytical methods (i.e., immunoassays, flow cytometry, functional assays), and formulations for Repertoire’s cell-based immunotherapies and biologics.  There will be GMP-facing responsibilities to enable robust in-process, process characterization, and release testing at QC laboratories, as well as authoring analytical sections of regulatory filings.  The candidate also will be expected to interface with third-party analytical/testing vendors and contract manufacturing organizations.  This work will support the development of Repertoire’s Deep-Primed™ natural TCR-based cell therapy platforms and biologics drug substance/drug products.

Responsibilities

  • Lead a team of experienced scientists and engineers focused on CMC Analytical Development for T cell therapies and biologics drug substances/drug products.
  • Oversee the design, development, and qualification of functional and potency assays for T cell therapy and biologic modalities with complex and multimodal mechanisms of action.
  • Develop and execute strategies for raw materials testing to support clinical cell therapy programs.
  • Work across teams to develop CMC-ready, phase-appropriate cell therapy analytical methods, and method validation strategies.
  • Assist in the definition and justification of specifications, retest/expiry period, storage, and shipping conditions.
  • Manage stability programs for cell therapies and biologics.
  • Author and review protocols, reports, and regulatory-filing sections.
  • Collaborate seamlessly with Repertoire colleagues in Tech Ops, R&D and Clinical, as well as with external organizations.
  • Communicate effectively across the organization via technical reports, presentations, SOPs, etc.

Qualifications

  • Ph.D. in a relevant scientific discipline (Bioengineering, Chemical Engineering, Cell Biology/Immunology, Molecular Biology, Biochemistry, etc.) with 8+ years biotech/pharma industry experience; cell therapy industry experience is highly desired.
  • In-depth knowledge and hands-on experience with cell and protein-based analytical techniques such as multi-color flow cytometry, multiplexed immunoassays, cell counting, cell-based assays, sequencing techniques, ddPCR/qPCR, HPLC.
  • Demonstrated experience with cell-based functional and potency assays, ideally with immune cells.
  • Good understanding of drug development process and regulatory guidelines; ability to implement in experimental design and planning.
  • Experience in method development, qualification/validation, and transfer in both large molecule/biologics and cell/gene therapy settings.
  • Good understanding of requirements for raw material controls.
  • Experience developing formulations suitable for cryopreservation of cell therapy drug products and process intermediates.
  • Experience overseeing studies at external vendors.
  • Demonstrated curiosity and ability to master new scientific disciplines and solve scientific/technical problems.
  • Strong interpersonal skills and superb verbal/written communication skills are essential in our ultra-collaborative work environment.
  • Desire to work in a faced-paced environment requiring the ability to solve challenging analytical questions and to develop assays that elucidate complex mechanisms of action and cell responses.

 

Repertoire is committed towards social responsibility and developing an inclusive culture.  Much as the power of the immune system lies in the diversity of T and B cells, our work requires the creativity and ingenuity of a diverse workforce.  We believe in actively pursuing equity in all facets of the work experience at Repertoire.  We will continue to educate ourselves about the inequities and barriers present in our society and take action as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.