Scientist/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
Scientist/Senior Scientist, Product Development

 Job Description

Senior Product Development Scientist will report to the Director of Product Development and will be based in Singapore. This candidate will be responsible for daily scientific experiments, method development, qualification, 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 in-house analytical methods in both scientific knowledge and hands-on skills for cell therapies
  • Perform experiments to support analytical methods development through qualification of release assays, transfer to Quality Control group for final product testing or used for characterization and/or regulatory filing.
  • Independently design, plan, execute and analyze data from in vitro studies to assess immunological function, potencies and for immune phenotyping for cell therapy products
  • Design protocols for evaluation clinical use stability for cell therapy products.
  • Support analytical work to identify critical parameters and reagents as well as acceptable operational ranges of the production processes
  • Identify critical quality attributes of the process intermediates and final products, and if needed, perform analytic work for these attributes
  • Perform training and technology transfer across laboratories and sites for cell therapy processes, including assistance in setting up a new pilot plant for supporting early clinical studies
  • Author SOPs and reports to document development efforts for analytical assays for cell therapy final products, in-process and raw materials
  • Support regulatory affairs’ filing in the product development area by providing key information and reviewing submissions
  • Assist in trend analysis of manufacturing lot release data after technology transfer, work with the production team for trouble shooting efforts, and advice in preventative actions to ensure long-term production success
  • Ensure laboratory housekeeping, maintenance of equipment, and inventories of reagents and consumables
  • Mentoring of junior scientists if required

Requirements

  • BS/MS in Immunology/Life Sciences with at least 5 years working in GxP environment. PhD is preferred for Senior role.
  • Extensive research development experience in immunology and/or molecular biology and/or Virology.
  • Strong understanding of immune system function and dysregulation, experience with various immune cell isolation techniques, including cell sorting
  • Familiar with cytotoxic and phenotyping assays for cellular products
  • Proficiency with FlowJo, FACSDiva software and statistical tools (ie JMP, PRISM) for data analysis
  • Experience with ELISPOT and other readouts of antigen-specific immune responses
  • Strong analytical skills and good scientific writing and presentation skills.
  • Good working attitude and willingness to learn
  • Good problem-solving and communication skills
  • Highly self-motivated and a good team player