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) – Process Manager/Associate Director
Head of Process Development
- Responsible for providing technical support to manufacturing operations to ensure that processes meet cGMP requirements and the product Critical Quality Attributes (CQAs) are met. The scope of activities includes process monitoring, deviation closure, technology transfer and troubleshooting of issues related to Tessa Therapeutics Cell Therapy product(s).
> Specifically, the team will prepare for process performance qualification, process monitoring, and optimization activities related to our Phase III manufacturing activities.
- Responsible for developing, mentoring and evaluating a small team of process experts to ensure effective operations of the MSAT team. Conducts performance reviews and drives goals setting and development activities for the team. Drive accountability for the timely closure of deviations, change control and qualification activities.
- Support quality, process development and manufacturing operations in ensuring the process control strategy is maintained and monitored, including at-line product and process characterization. Support process development and regulatory affairs in creating, reviewing and outlining submission packages or briefings as required.
- Develop process troubleshooting and process monitoring trending systems and tools that align with the QMS and are part of the continued process verification plan (CPV).
- 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 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 or with 5 years or more relevant experience in cGMP environment for Biologics/Vaccines/ CMC activities.
- Experience with cell therapies desirable.
- Prior experience in process troubleshooting, deviation writing and executing change controls, particularly in a clinical or manufacturing setting.
- Experience in fronting regulatory audits, particularly Pre-approval Inspections (PAIs)
- Ability to demonstrate both technical leadership and team leadership
- Experience in developing process monitoring and trending programs
- Flexible and proactive in working on solving issues and problems, particularly using Six Sigma tools (e.g. DMAIC).
- 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.
- Experience in operational excellence tools desirable.
- Comply to Tess safety practices and standard operating procedures
- Exhibit and promote Tessa’s Core Values
- Proficient in statistical analysis and technical writing.