Senior Expert, Technology Validation

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

Job Position
Senior Expert, Technology Validation

Responsibilities

  • Responsible for developing qualification/validation strategy and lifecycle documents (validation plan, user requirement specification, risk assessments, design qualification, commissioning qualification validation protocols/reports, configuration specification, traceability matrices) includes Facility, Utilities, Equipment (FUE) commissioning qualification validation, Analytical Instrument Qualification, Process Validation, Sterilization Validation, Shipping Validation, Aseptic Process Simulation according to current GxP regulations and Tessa Quality Management Systems to ensure compliance within a cell therapy manufacturing environment.
  • Responsible for validation lifecycle maintenance of the systems and processes including deviation system, change control impact assessment, validation maintenance activities in periodic review and periodic revalidation.
  • Serves as computerized system application administrator for FUE and Analytical Instruments to support site operations.
  • Develop and maintenance of computerized system application administrator procedures.
  • Provide support and represent Technology Validation for filings, audits and regulatory inspection.
  • Responsible, plans, monitors and report the day-to-day validation operations.
  • Prioritize portfolio of activities as well as communicate the risks associated with the validation strategy.

Requirements

  • Master’s 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.
  • Deep understanding in cGMP validation requirement and trends
  • Ability to drive decision making within a multi-disciplinary, multi-region matrix team.
  • Experience with cell therapies is desirable
  • 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 operations.
  • Innovation in developing new ideas for validation process improvements and in completing cross-functional improvements programs for cell therapy operations.
  • Self-starter with the ability drive validation projects in a multi-disciplinary, multi-region matrix team
  • 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.