Manager, Cell Therapy QC

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 currently 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

Repertoire is seeking a highly motivated Quality Control (QC) professional to join the growing cell therapy analytical development/quality control team in a high visibility role within technical operations.  The successful candidate will lead ongoing external QC operations at Repertoire as well as at contract facilities.  You will work closely in a cross-functional team of quality assurance, manufacturing sciences, supply chain, and analytical development/quality control to support lot release and characterization of the ongoing clinical supply campaign for the cell therapy and biologics product pipelines.

Key Responsibilities

  • Manage external QC in process and release testing performed at contract facilities.
  • Work collaboratively with cross-functional teams to identify and lead improvements for QC operations ongoing internally and externally at contract facilities.
  • Support batch release via owning quality system records including change controls, CAPA(s), deviations, and OOS/OOT investigations.
  • Project and timeline management of QC lifecycle activities ongoing internally and externally at contract facilities.
  • Oversight and management of stability studies including authoring of technical reports.
  • Evaluation and implementation of electronic system and procedure for entry, traceability, and shareability of QC data used for quality and regulatory purposes as well as product/process characterization.
  • Support efforts to establish critical reagent and method monitoring programs.
  • Support with QC logistics including contribution to sample management procedure and best practices for inventory management.
  • Support authoring and review of regulatory filing content including stability and batch release.

Qualifications/Experience

  • Minimum B.S. in a scientific or biotechnology discipline with 5 plus years’ experience in a Quality Control unit that employs GMP for testing of biologics (cell or gene therapy preferred).
  • Demonstrated ability to manage external partners and/or QC laboratory operations is a must.
  • Extensive experience in owning quality system records including change controls, CAPA(s), deviations, OOS/ OOT investigations is a must.
  • Willingness to travel domestically once a month is strongly preferred.
  • Proven ability to operationalize QC processes and procedures which adhere to regulatory guidance and industry best practices for clinical phase cell and gene therapy products.
  • Preferred knowledge in Smartsheet, JMP for statistical analysis, Trackwise, and LIMS.
  • Experience supporting clinical phase cell or gene therapy products.
  • Strong interpersonal skills including verbal and written communication skills are essential in our ultra-collaborative work environment.

 

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, we believe that our work requires the creativity and ingenuity of a diverse workforce, and we are committed to pursuing that 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 act as a company where we can make a difference.

Repertoire is proud to be an Equal Opportunity Employer.