Analytical Development Scientist

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

 

Job Position
Analytical Development Scientist

Reports to
Analytical Development Manager

Job Description

  • Responsible for carrying out analyses, developing and optimize methods for process and product characterization for various cell therapy products. In particular, work to establish method for BLA product characterization package for our Phase III product, including physiochemical and biological characterization tools.
  • Participate in development lifecycle Chemistry, Manufacturing and Controls (CMC) qualification activities related to assay/method selection, establishment, technology transfer and as required, qualification. Specifically, expertise in T cell characterization, immunology biological assay.
  • Competent in at least two type of immunological assays such as flow cytometry or ELISPOT.
  • Support quality/quality control, process development, hospital operations, and manufacturing operations in closing of deviations, impact assessments for change controls. Support technology transfer activities as required.
  • Support the collaboration with our research and development team as well as external contractors/partners for the development of the assays.
  • Maintain all documents related to the development of assays according to GDP principles. Maintain strong working relationships with inter-department stakeholders as well as external contractors
  • Conduct experimental procedures to establish, optimize and qualify analytical methods. Ensure maintenance and operations of the analytical laboratory.
  • Communicate effectively across functions. Ensure a timely execution of analytical activities.
  • Participate in organizational activities including due-diligence meetings, organizational development and team building activities to further the culture of Tessa Therapeutics.

 Requirements

  • PhD/Master’s Degree in Analytical Sciences/Biotechnology/life sciences/Immunology or any related field with at least 5 years of relevant working experience in Biologics/Vaccines/ CMC activities.
  • Experience with cell therapy assays (e.g. flow cytometry/ ELISPOT) is desirable
  • Relevant experience in cell-based assay development, product and process characterization, particularly in a clinical or manufacturing setting.
  • Understanding of immunology biological assays would be desirable.
  • Understanding of ICH Q2 and ICH Q6B requirements and basic quality control cGMP workflows
  • Flexible and proactive in working on solving issues and problems
  • Comply to Tessa’s safety practices and standard operating procedures
  • Exhibit and promote Tessa’s Core Values
  • Proficient in statistical analysis and technical writing.