About Tessa Therapeutics
Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.
Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.
Tessa has built up robust operational and supply chain capabilities to successfully deliver T 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 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 team.
Senior Scientist / Manager, Process, Science and Technology (PSAT)
Senior Director, Process, Science and Technology
As part of the process development, the successful candidate will be leading a team of scientist in the area of cell therapy process optimization efforts in areas such as – (i) characterize product and processes, (ii) improve predictive consistency and workflow efficiency, (iii) product characterization, (iv) automation strategies, among others.
What you will do:
- Independent hands-on bench work in the isolation, culture (tissue culture vessels, bags, bioreactors), and characterization of cells under cGMP conditions
- Lead and guide team members to identify, design and execute technical and methodological solutions to a wide range of complex manufacturing issues; including transition and implementation to GMP-compliant use
- Develop and execute scientifically sound strategies for (i) process comparability relating to late stage regulatory submissions, and (ii) raw material qualification for clinical and commercial manufacturing
- Organize team to perform characterization studies of final product T cells
- Provide scientific guidance to the team on the methodology for executing experiments
- Evaluate automation technologies for implementation into process development
- Create and manage documents and raw data for future reference or for use in developing central technical documents. This includes ensuring data is regularly checked and verified by a second person.
- Use external and internal references to create technical assessments and justifications for the process and product.
- Report and escalate issues impacting and resulting in delays in the timelines
- Support manufacturing investigations as required.
- Work collaboratively with other departments and within the PSAT department to achieve the goals, including the transfer of processes to manufacturing.
To excel you will need to:
- Be able to bridge scientific aspect of T cell immunology with GMP manufacturing requirements.
- Think beyond the scientific scope toward cGMP requirements.
- Lead, manage and prioritize activities in the team to meet objectives and timeline
- Develop templates, systems and platforms required for smooth running and tracking of department activities
- Develop and execute detailed project plans (including budget and resource requirements)
- Provide timely status reports, presentation and analysis to department head
- Support department head in other strategic department initiatives
- Provide guidance and supervision junior staff or manufacturing biotechnologist in areas of:
- Cell culture techniques and scientific knowledge
- Writing of technical reports and presentation
- Preparing SOP, batch records and product specifications documentation in compliance to cGMP guidelines
- Other ad-hoc duties/projects
- PhD. in biological science, immunology, T cell therapy, chemical/biological engineering or other related scientific discipline (Bachelors and Master’s degree are welcome to apply)
- At least 5 years of relevant industry experience
- Exceptional aseptic technique and primary cell culture skills, with experience in:
- handling cells populations typically include T cells, dendritic cells and derivatives thereof intended for infusion, and
- use of well plates, T flask, and other small scale bioreactors
- Experience with automated, large scale cell processing and selection systems for processing human blood products
- Hands on experience in flow cytometry/ Immunoassays like cytokine release assays
- Good understanding of principles of cGMP, FDA compliance, raw materials and documentation requirements
- Excellent organizational and problem solving skills
- Details oriented and able to work effectively in a fast paced, rapid changing environment
- Good collaborative, interpersonal and communications skills
- Highly proficient in MS Word, Excel, PowerPoint, SharePoint, Outlook
- Exhibit and promote Tessa’s Core Values
- Proficient in statistical analysis and technical writing
- Travelling is a must and willingness to have a flexible schedule when needed