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 Manager / Manager, Manufacturing
- Develop and maintain Job aids, Training materials and curricula related to process operations, and process theories with the support of Manufacturing Managers and MFG Specialist / Biotechnologists.
- Create Safety Risk Assessment (using tools such as pFMEA, HAZID, HAZOP) related to usage of process equipment and process operations.
- Support and perform cell manufacturing related activities according to written Batch Manufacturing Records (BMRs) and associated Standard Operating Procedures (SOPs).
- Adhere to strict aseptic techniques and sterile manufacturing guidelines when performing cell therapy production in the Training Lab or Good Manufacturing Practice (GMP) cleanroom facility.
- Document production activities and outcomes using Good Documentation Practices (GDP) in the corresponding batch records and log sheets
- Clean and perform basic maintenance of process equipment and cleanroom according to SOPs
- Assist and perform inventory planning and control in the cleanroom through Kanban and 5S workflows.
- Assist in Quality Management System aspects of cleanroom management including deviation investigations, CAPA implementation and change control assessments.
- Degree in Pharmaceutical Engineering/Biotechnology/Chemical Engineering/Bioengineering/Life Sciences or any related field.
- Previous experience in the biopharmaceutical or related environment is a plus. Applicant must be familiar with a GMP environment and compliance expectations in a cleanroom manufacturing area.
- Competent in MS Excel (able to use Pivot Tables, Condition Formatting and other basic formulas), MS Word (familiar with the use of Styles, and other basic formatting tools) and MS PowerPoint.
- Good communication skills and able to be a team player.
- Passionate, self-motivated and willingness to learn.
- Ability to work long hours occasionally when required.
- Strong technical writing abilities.
- Good analytical, planning and coordination skills.