Senior Expert / Expert, MSAT Process

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T 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 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,
    • technical assessment 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.
    • Tech Transfer for new product or facility
  • Responsible for mentoring Junior team member, including providing technical decision making.
  • Provide timely technical assessment for deviations, change control, and qualification activities
  • Accountable for timely support and closure of process related deviation, change control, qualification and Technology Transfer 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).
  • Support or lead Technology transfer for new product / facility
  • 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’s degree/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
  • Experience in tech transfer
  • 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.
  • Good time management
  • 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.
  • Requires to travel up to 20% of the job