Senior Manager, Biologics CMC Analytical Development

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

We are seeking a talented Senior Manager to join the rapidly growing analytical development/quality control team.  The successful candidate will lead analytical method development, transfer, and qualification to advance Repertoire’s multiple clinical programs.  This is a key role in the technical operations organization that will work closely with process development, manufacturing, supply chain, quality assurance, and external organizations.

This is an opportunity to ensure the availability of innovative cytokine-based biologic modalities for use in 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 strong technical understanding of bioanalytical/biochemical methods, keen attention to detail, understanding of analytical regulatory expectations and knowledge of guidance for the biologics industry.  You will leverage a strong technical background in analytical method development and method qualification with immunoassays and protein-based methods (e.g., HPLC, titers, binding) to enable the QC testing and analytical characterization of biologic modalities produced as part of Repertoire’s clinical development pipeline.

Key Responsibilities

  • Collaborate with R&D and process development teams to develop analytical methods, draft SOPs and reports, contribute to internal biological/cell therapy analytical testing activities and IND filings.
  • Lead method transfer and trouble-shooting activities with multiple external manufacturing and testing organizations; occasional travel may be required.
  • Review analytical data, SOPs and batch records, lead investigations of deviations, invalid assays, and other non-conformance incidents from GMP manufacturing and QC testing.
  • Develop and manage timelines and budgets with external testing organizations.
  • Manage sample retains, stability programs, and inventory.

Qualifications/Experience

  • Ph.D. in Life Sciences, Analytical Chemistry, or Chemical/Bio Engineering with 5+ years of industry or experience or B.S./M.S. with 8+ years of industry experience in biologics analytical development or QC.
  • Experience with a variety of protein analytical and characterization techniques such as UV-Vis, RP-HPLC, SEC, LC-MS, SDS-PAGE, CE-SDS, iCIEF, PCR, immunoassays, and bioassays.
  • Experience or knowledge with microbiology methods such as bioburden, endotoxin, sterility, etc. is preferred.
  • Experience or knowledge in flow cytometry and cell characterization is a plus.
  • Desire to independently develop and troubleshoot analytical methods.
  • Experience or knowledge in method qualification/validation, release, and stability testing.
  • Good understanding of cGMP regulations and ICH/quality guidelines.
  • Experience working with CDMOs/CROs preferred.
  • Excellent interpersonal skills and ability to work with cross-functional stakeholders.
  • Highly organized, attention to detail, and ability to deliver in an accelerated 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.