Principle/Senior Scientist, Product Development

Company Background

Tessa Therapeutics is a clinical-stage cell therapy company focused on the development of autologous and off-the-shelf, allogeneic therapies to treat cancer. Tessa’s Virus-Specific T cell (VST) technology platform harnesses the body’s potent anti-viral immune response and has shown early efficacy and a strong safety profile against solid tumors in clinical trials.

Tessa is building a portfolio of innovative, next-generation therapies through combination approaches and other novel immuno-oncology technologies. This portfolio includes a rapidly growing clinical pipeline that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, head and neck cancer, and lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our global team of over 200 employees is passionate about bringing life-saving cancer treatments to patients all over the world. If this excites you too, explore our job opportunities and see if there’s a match.

For more information on Tessa, please visit www.tessatherapeutics.com.

Job Position
Principle / Senior Scientist, Product Development

 Job Description

Principal/Senior Scientist will report to the VP of Product Development and be based in Singapore. This candidate 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 is 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