Associate Director, Cell Therapy Quality Control

Operations 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 currently using its proprietary platform to discover novel epitopes and TCRs from patients with type 1 diabetes.  However, we are currently expanding our remit into other autoimmune disorders.  The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.

Role Overview

We are seeking a highly motivated and experienced quality control professional to join the rapidly growing Cell Therapy Analytical Development/Quality Control team.  The role will be responsible for ensuring product release of multi-antigen, cytokine-enhanced T cell therapies (the DEPLOY platform) to advance Repertoire’s multiple clinical programs.  This is a high visibility role in the Technical Operations organization that will work closely with external organization, Clinical Operations, and Process Development/Manufacturing.

This is an opportunity to ensure the release of safe and efficacious cell therapy Drug Substance/Drug Product for use in innovative clinical trials that benefit patient lives.  The position will work with external CDMOs on analytical method transfers, method qualification/validation strategies, and lifecycle improvements for raw materials, in-process, safety, and QC release testing.  The GMP-facing nature of this work requires keen attention to detail, understanding of analytical regulatory expectations, and knowledge of guidance for the cell and gene therapy industry.  You will leverage a strong technical background in analytical method development and method qualification with ELISAs, flow cytometry, cell counting, and protein-based methods (e.g., HPLC, titers) to improve the QC testing of biologics and cell therapy drug substance/drug product.

Key Responsibilities

  • Manage external CRO’s and CDMO’s with oversight to cell therapy and biologics manufacturing and QC testing; occasional travel may be required.
  • Design method qualification/validation strategies and lifecycle improvements for raw materials, in-process, and release testing of biologics and cell therapy products.
  • Lead method transfer activities with multiple external organizations.
  • Develop methods, draft Standard Operating Procedures, and contribute to internal analytical testing activities.
  • Lead investigations of deviations, invalid assays, and other non-conformance issues related to GMP manufacturing and QC testing.
  • Manage sample retains and inventory.
  • Contribute to IND filings.

Qualifications/Experience

  • M.S./Ph.D. in Life Sciences, Analytical Chemistry, or Chemical/Bio Engineering with 8 plus years of relevant industry experience in biologics analytical development or QC; previous experience in cell and gene therapy industry highly preferred.
  • Experience with a wide variety of QC testing modalities including flow cytometry, immunoassays, bioassays, cell-based assays, and HPLC.
  • Experience with microbiology methods such as bioburden, endotoxin, sterility, etc.
  • Experience working in a regulated environment is preferred.
  • Excellent interpersonal skills and ability to work with cross-functional stakeholders.
  • Excellent written communication skills as demonstrated though technical report writing or IND filings.
  • Highly organized, attention to detail, and ability to focus and deliver in a fast-paced environment.
  • Previous experience managing a group.

 

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.