Senior / Manager, MSAT Validation

Company Background

Tessa Therapeutics is a clinical-stage cell therapy company focused on the development of autologous and off-the-shelf, allogeneic therapies to treat cancer. Tessa’s Virus-Specific T cell (VST) technology platform harnesses the body’s potent anti-viral immune response and has shown early efficacy and a strong safety profile against solid tumors in clinical trials.

Tessa is building a portfolio of innovative, next-generation therapies through combination approaches and other novel immuno-oncology technologies. This portfolio includes a rapidly growing clinical pipeline that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, head and neck cancer, and lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver 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 global team of over 200 employees is passionate about bringing life-saving cancer treatments to patients all over the world. If this excites you too, explore our job opportunities and see if there’s a match.

For more information on Tessa, please visit www.tessatherapeutics.com.

Job Position
Senior / Manager, MSAT Validation

Reports To
Director, MSAT Validation

 Job Description

  • Serve as a CSV Subject Matter Expert in analytical instrument and process equipment including SCADA / environmental monitoring system
  • Develop and manage lifecycle validation projects and lifecycle documentations (validation plan, user requirement specification, risk assessments, design qualification, commissioning qualification validation protocols/reports, configuration specification, traceability matrices) for GxP systems within a cell therapy manufacturing environment.
  • Design, author, and execute commissioning qualification validation protocols in support of capital and tech transfer projects for analytical instrument, process equipment, utilities and facilities, focusing on the computerized system validation aspects
  • Support equipment/system selection within procurement process to ensure computerized system and data integrity compliance
  • Design and develop risk-based ASTM2500E integrated CQV approaches for various validation activities
  • Support and coordinate discrepancy resolution and close out.
  • Maintain a state of validation once the lifecycle of the system has been fully qualified/validated. Maintain all qualification/validation documents within the QMS.
  • Serve as the CSV subject matter expert in supporting regulatory audit, BLA, change controls, deviations, and CAPAs
  • 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 8 years of relevant working experience in cGMP environment for Biologics/Vaccines/ CMC activities.
  • Experience with cell therapies is desirable
  • Thorough knowledge of validation life cycle including 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5, Data Integrity and ASTM2500E requirements
  • Must have experience in analytical instrument qualification and process equipment qualification
  • Experience in qualification/validation of Network Infrastructure, Laboratory Information System, Enterprise Systems is a plus
  • Experience in other validation area (such as media fills/APS, process validation etc) is a plus
  • Project and people management experience preferred
  • 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