Principal/Senior Scientist, Product Development

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on cancer treatment through the development of autologous and allogeneic cell therapies for a range of cancers.

Our portfolio of next-generation therapies is derived from two innovative technologies: CD30-Chimeric Antigen Receptors (CD30-CARs) and a specific subset of T cells known as Virus-Specific T Cells (VSTs). We are also developing a novel, allogeneic platform technology that combines the unique properties of CD30-CARs and VSTs. This platform anchors our 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, expected to be ready in 2021, will substantially enhance in-house production capabilities and ensure that patients can benefit from our cell therapies more rapidly.

Patients are at the heart of what we do. Our mission is to change cancer treatment and give patients a new lease on life. We are looking for team members who have a passion for creating breakthroughs in cancer treatment. We want to work with people who seek to go beyond, and to pioneer new innovations. You can find out more about our company by visiting our website: www.tessatherapeutics.com.

Job Position
Principal/Senior Scientist, Product Development

Job Description

Principal/Senior Scientist will report to the VP of Product Development and be based in Singapore. He/she will be responsible for designing and executing experiments towards deeper scientific understanding of safety and efficacy characteristics of Tessa’s cell therapy products in alignment to project timelines and strategies. He/she will also support regulatory filing for product-related scientific matters and work with cross-functional teams, including external collaborators, to ensure product quality and consistency

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
  • 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
  • Support regulatory affairs’ filing in the product development area by providing key information in writing and reviewing submissions
  • 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

  • PhD in Immunology or Life Sciences with at least 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
  • Proficiency with special software such as FlowJo, FACSDiva as well as data analysis tools (ie PRISM, JMP)
  • 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