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.
Analytical Development Manager / Associate Director
Head of Process Development
- Responsible to lead a team of analytical scientist to establish process and product characterization methods for various cell therapy products. In particular, define and develop a BLA product characterization package for our Phase III product, including physiochemical and biological characterization tools.
- Participate in development lifecycle Chemistry, Manufacturing and Controls (CMC) qualification activities related to assay/method selection, establishment, technology transfer and as required, qualification. Specifically, expertise in T cell characterization, immunology biological assay.
- Establishing scientifically sound assays for key assays related to flow cytometry, ELISPOT as well as other single-cell analysis methods
- Responsible for recruiting, developing, mentoring and evaluating a small team of scientists to ensure effective operations of the analytical development group. Conducts performance reviews and drives goals setting and development activities for the team. Drive accountability for the timely execution of analytical development activities.
- Support quality/quality control, process development, hospital operations, and manufacturing operations in closing of deviations, impact assessments for change controls. Support technology transfer activities as required. Support regulatory affairs in creating, reviewing and outlining CMC packages for submissions or briefings.
- Maintain a portfolio of assays through the collaboration with our research and development team as well as external contractors/partners.
- Maintain all documents related to the development of assays according to GDP principles.
- Maintain strong working relationships with inter-department stakeholders as well as external contractors As required, conduct experimental procedures to establish, optimize and qualify analytical methods. Ensure maintenance and operations of the analytical laboratory.
- Establish product and process characterization strategies, including procedures and accountability metrics for the team. Prioritize portfolio of activities as well as understand/ communicate the risks associated with the 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.
- PhD./Masters Degree in Analytical Sciences/Biotechnology/life sciences/Immunology or any related field with at least 8 years of relevant working experience in Biologics/Vaccines/ CMC activities.
- Experience with cell therapy assays (e.g. flow cytometry/ ELISPOT) is desirable
- Relevant experience in cell-based assay development, product and process characterization, particularly in a clinical or manufacturing setting.
- Understanding of immunology biological assays would be desirable.
- Ability to demonstrate both technical leadership and team leadership
- Demonstrate innovative thought processes to develop characterization packages
- Proficient in ICH Q2 and ICH Q6B requirements and basic quality control cGMP workflows
- Flexible and proactive in working on solving issues and problems