Senior/Associate Principal Scientist, Analytical Science

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

Job Position
Senior/Associate Principal Scientist, Analytical Science

Job Description

  • Learn and master the cell therapy production processes and related analytical methods in both scientific knowledge and hands-on skills
  • Understand GMP regulation for manufacturing cell therapies and performing lot release assays and integrate them into approaches for consistent production of high-quality clinical trial materials for Tessa’s early and late phase clinical studies
  • Lead the deep scientific understanding of Tessa’s cell therapy products by designing and conducting in vitro characterization assays and establishing appropriate routine characterization and lot release assays for in-process and final products.
  • Independently explore novel in vitro studies to meaningfully assess immunological and mechanism-of-action functions of intermediates and final cell therapy products
  • Develop and qualify assays that will be transferred to the Quality Control group or used for characterization and/or regulatory filing.
  • Identify critical quality attributes of the process intermediates, and final products, and perform analytic work for these attributes
  • Establish critical parameters and reagents as well as acceptable operational ranges of the cell therapy products and their in-process materials or critical process steps
  • Collaborate with the in vivo pharmacology and research groups towards a deeper understanding of underlining biology for products and correlation to clinical outcome
  • Perform training and technology transfer of assays across laboratories and sites for cell therapy assays and/or processes
  • Author reports documenting development efforts for product characterization and quality control of cell therapy products, intermediates, and critical reagents
  • Lead the effort in providing characterization product analysis for long-term monitoring of manufacturing processes after technology transfer, work with the production team for troubleshooting efforts, and advice in preventative actions to ensure long-term production success
  • Mentoring junior scientists, if required.

Requirements

  • MSC/Ph.D. in Immunology or Life Sciences with at least 5-7 years of experience working in developing therapeutic biological drugs; experience with cell therapy and CMC knowledge is highly preferred. Applicants with BSc and extensive experience in developing and qualifying analytical lot release assays will also be considered.
  • Strong understanding of the immune system and dysregulation and excellent hands-on skills in various immune research techniques (Flow, ELISA, and ELISPOT assays), AND/OR
  • Technical and hands-on experience in developing genetic and genomic assays for product release and characterization, i.e., RCR qPCR assays, Viral Copy Number assays using ddPCR, and experience with NGS sequencing methods and analysis.
  • Knowledge and experience working with viral vectors and characterization
  • Strong analytical skills and good scientific writing and presentation skills.
  • Good problem-solving and communication skills
  • Highly self-motivated and a good team player
  • Experience with statistical analysis using JMP, Prism, and setting up DOE studies will be highly preferred.
  • Ability to work well under pressure and challenging timelines