Manufacturing Science & Technology (MSAT) Senior Validation Expert

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 Process Development team.

 

Job Position
Manufacturing Science and Technology (MSAT) – Senior Validation Expert

Reports to
MSAT Validation Manager

Job Description

  • Serves as a technical expert for lifecycle Chemistry, Manufacturing and Controls (CMC) qualification and validation activities. In particular, late stage validation/qualification activities related to our Phase III/ BLA submission validation activities.
  • Expertise in at least two areas, for example; process validation, auxiliary process qualification, shipping validation and other CMC validation packages such as extractables and leachables, container closure studies, extractable volume studies and in-use studies.
  • Support quality, process development, hospital operations, supply chain and manufacturing operations in closing of deviations, impact assessments for change controls and other validation documentation systems. Support other qualification activities which are not owned with in the MSAT Validation scope, including stability studies, assay validation and computer systems validation. Support technology transfer activities as required. Support regulatory affairs in creating, reviewing and outlining CMC packages for submissions or briefings.
  • Create validation and qualification strategies, including protocol writing, review of raw data and generation of final reports. Support execution of protocols, including training, preparation of materials and coordination of teams.
  • Maintain a state of validation once the lifecycle of the system has been fully qualified. Maintain all qualification/validation documents with the QMS.
  • 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 validation activities. Engage in both technical and tactical discussions to ensure stakeholder alignment.
  • Participate in organizational activities including due-diligence meetings, organizational development and team building activities to further the culture of Tessa Therapeutics.

Requirements

  • Master Degree/Degree in Engineering or Biotechnology or any related field with at least 6 years of relevant working experience in cGMP environment for Biologics/Vaccines/ CMC activities.
  • Experience with cell therapies is desirable
  • Prior experience in process validation, shipping validation and other validation activities, particularly in a clinical or manufacturing setting. Deep understanding of cGMP validation requirements and trends
  • Experience in fronting regulatory audits, particularly Pre-approval Inspections (PAIs)
  • Able to think outside the box to develop and execute validation strategies for cell therapy applications.
  • Flexible and proactive in working on solving issues and problems
  • Self-starter with the ability drive validation projects in a multi-disciplinary, multi-region matrix team
  • Able to communicate with impact, ensuring alignment and negotiating positive outcomes in his/her area of work.
  • Comply to Tess safety practices and standard operating procedures
  • Exhibit and promote Tessa’s Core Values
  • Proficient in statistical analysis and technical writing.