Senior Expert / Expert, MSAT Process

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
Senior Expert / Expert, MSAT Process

Reports To
Senior Manager, MSAT Process

 Job Description

  • Responsible for technical support to manufacturing operations to ensure that processes meet cGMP requirements and the product Critical Quality Attributes (CQAs) are met. The scope of activities includes
    • data collection,
    • process monitoring,
    • deviation closure,
    • troubleshooting of issues related to Tessa Therapeutics Cell Therapy product(s).
    • specifically, execute for process qualification, process monitoring, and optimization activities related to our Phase III manufacturing activities.
  • Responsible for mentoring Junior team member, including providing technical decision making.
  • Accountable for the timely closure of deviations, change control and qualification activities.
  • Support quality, process development and manufacturing operations in ensuring the process control strategy is maintained and monitored, including at-line product and process characterization.
  • Support in the development of process troubleshooting and process monitoring trending systems and tools that align with the QMS and are part of the continued process verification plan (CPV).
  • Maintain strong working relationships with inter-department stakeholders as well as external contractors
  • Communicate effectively across functions. Align goals and priorities for the timely execution of activities. Engage in both technical and tactical discussions to ensure stakeholder alignment.
  • Excellent team player with willingness to learn, share and find solutions together with the team.
  • Participate in organizational activities including due-diligence meetings, organizational development and team building activities to further the culture of Tessa Therapeutics.

Requirements

  • Master/Degree in Engineering or Biotechnology or any related field with at least 5 years of relevant working experience
  • Experience with cell therapies preferable alternatively, strong ability to learn.
  • Prior experience in process troubleshooting, deviation writing and executing change controls, particularly in a clinical or commercial manufacturing setting.
  • Experience in process monitoring
  • Flexible and proactive in working on solving issues and problems, particularly using Six Sigma tools (e.g. DMAIC).
  • Able to communicate with impact, ensuring alignment and negotiating positive outcomes in his/her area of work.
  • An excellent team player with willingness to learn, share and find solutions together with the team.
  • Ability to work independently with minimum supervision.
  • Proficient in statistical analysis and technical writing.
  • Willing to travel 25% of the time to Malaysia office