Tessa Therapeutics is a leading biotechnology company specializing in the research, clinical development, and commercialization of cancer immunotherapy treatments. We are a global leader in employing Virus-Specific T cells (VST) to treat cancer. We are currently conducting the world’s first US FDA-registered Phase III T cell therapy trial in NPC, or any cancer indication. We have multiple recruitment sites in the following countries: Singapore, Malaysia, Taiwan, Thailand, and the US. In addition, we have a robust pipeline of both pre-clinical and clinical treatments, targeting multiple cancer indications.
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.
Manufacturing Science and Technology (MSAT) – Validation Manager/Associate Director
Head of Process Development
- Responsible 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. Specifically, expertise in process validation, auxiliary process qualification, shipping validation and other validation activities with regards to CMC packages include but not limited to extractables and leachables, container closure studies, extractable volume studies and in-use studies.
- Responsible for recruiting, developing, mentoring and evaluating a small team to ensure effective operations of the MSAT Validation group. Conducts performance reviews and drives goals setting and development activities for the team. Drive accountability for the timely execution of validation and qualification activities.
- 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.
- 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
- Establish qualification and validation strategies, including procedures and accountability metrics for the team. Prioritize portfolio of activities as well as understand/ communicate the risks associated with the validation strategy.
- 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.
- 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
- 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)
- Ability to demonstrate both technical leadership and team leadership
- 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
- Ability to drive decision making within 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 Tessa’s safety practices and standard operating procedures
- Exhibit and promote Tessa’s Core Values
- Proficient in statistical analysis and technical writing.