Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create 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 Process Development team.
Process Development Scientist I/II
Head of Process Development or Process Development Manager
- As part of the process development, the successful candidate will be leading cell culture process development efforts in areas such as – (i) characterize product and processes, (ii) improve predictive consistency and workflow efficiency, (iii) product characterisation, (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
- Work with 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
- Perform characterization studies of final product T cells
- 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 department to achieve the goals
To excel you will need to:
- Manage and prioritize process and product characterization activities with 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
- Ph.D. in biological science, immunology, chemical/biological Engineering or other related scientific discipline (Bachelors and Master’s degree are welcome to apply)
- At least 2 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