Senior Scientist, 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 highly motivated analytical development professional to join the growing analytical development/QC department.  The successful candidate will play a lead role in analytical method development and process/product characterization efforts supporting the development of our biologic drug substance/drug product injectable cytokine platforms.  They will work closely with external organizations to support release, stability, and characterization testing using a variety of product-specific analytical techniques.  Their lab-based work will inform method optimization and analytical lifecycle activities supporting Repertoire’s clinical programs.  In this role, you will work closely in a cross-functional team of immunologists, analytical chemists, protein scientists, manufacturing experts, and assay developers to support analytical method development/optimization, product characterization, and process development efforts.

A self-starting attitude and the ability to focus and execute in a fast-paced, dynamic, and highly collaborative environment is a must.  You should set the example of leading by doing.  There is a significant opportunity for career growth and continuous learning in the highly collaborative Repertoire work environment.

Responsibilities

  • Develop, qualify, and transfer analytical methods for cytokines, fusion proteins, peptides, and other biologics in collaboration with internal and external teams.
  • Implement methods to support raw material testing, DS/DP product release, stability programs, and product characterization/elucidation of structure.
  • Transfer analytical methods to external CROs/CDMOs and provide additional training, troubleshooting, or technical support, as necessary.
  • Manage analytical and stability programs at CROs.
  • Author SOPs and development reports.
  • Contribute to CMC sections of regulatory filings.
  • Serve as biologics analytical SME for external and internal stakeholders.
  • Identify and implement innovative techniques and technologies to improve product and process understanding.
  • Desire to lead from the bench when necessary, with ownership over experimental design, analysis, documentation, and hiring/training/supervision of junior staff.

Qualifications

  • M.S./Ph.D. in a relevant scientific discipline (Analytical Chemistry, Bioengineering, Molecular Biology, Biochemistry, etc.) with 5+ years relevant industry experience.
  • Demonstrated ability to develop and optimize analytical methods for the characterization of biologics using principles from ICH and regulatory standards.
  • Experience working on biologics drug substance/drug product in the biotech/pharma industry is highly preferred.
  • Knowledge of biologics CMC development from pre-clinical through later-phase clinical development.
  • In-depth knowledge and hands-on experience of a variety of analytical, biochemical, and molecular biology techniques such as HPLC, LC-MS, CE-SDS, cIEF, ELISA, higher order structure, and cell-based assays.
  • Demonstrated ability to design and execute complex characterization assays.
  • Previous experience managing a group and/or external projects at CROs.
  • Familiarity with compendial drug product testing methods is a plus.
  • Demonstrated curiosity and ability to master new scientific disciplines and troubleshoot technical, regulatory, and scientific problems.
  • 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, 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.