(Senior) Scientist, Product Development

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
(Senior) Scientist, Product Development

 Job Description

Scientist/Senior Scientist will report to the Director of Product Development and be based in Singapore. This candidate will be responsible for planning and executing experiments towards deeper scientific understanding of safety and efficacy characteristics of Tessa’s cell therapy products.  He/She will develop, qualify, and perform data analysis as well as technology transfers across functional laboratories for cell therapy processes in alignment to project timelines and strategies for Product Development.

Responsibilities

  • Learn and master the cell therapy production processes and related analytical methods in both scientific knowledge and hands-on skills
  • Understand the GMP regulation for manufacturing of cell therapies and conducting lot release assays and integrate them into approaches for consistent production of high-quality clinical trial materials for Tessa’s early phase clinical studies
  • Lead the effort of deep scientific understanding of Tessa’s cell therapy products by designing and conducting in vitro characterization assays and establish 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 Quality Control group or used for characterization and/or regulatory filing.
  • Identify critical quality attributes of the process intermediates, 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 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 to document 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 manufacturing processes after technology transfer, work with the production team for trouble shooting efforts, and advice in preventative actions to ensure long-term production success
  • Mentoring of junior scientists if required

Requirements

  • Bachelor’s Degree/Master’s Degree in Immunology or Life Sciences with at least 3-5 years of experience working in developing therapeutic biological drugs; experience with cell therapy and CMC knowledge are highly preferred
  • Strong understanding of immune system and dysregulation and excellent hands-on skills in various immune research techniques
  • 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  
  • Ability to work well under pressure and challenging timelines