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 team.
Senior/Quality Operations Executive
Senior Manager, Quality Operations
This role is responsible for the execution of daily quality operation activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility. Area of responsibilities include, but not limited to:
- Provide quality oversight to ensure manufacture of cell therapy products is in compliance with Company procedures and cGMP regulations.
- Review of completed batch records to ensure compliance with GMP per written procedures
- Support establishment of and review and/or approve Master Batch Records
- Review and/or approval of GMP relevant documents not limited to SOPs, work instructions, protocols, summary reports
- Support and prepare batch documentation for lot disposition
- Review/approve manufacturing-related quality issues and investigations (e.g. deviations, trends, Out-of-Specification), to ensure their proper and timely completion, including that of the corresponding corrective and preventive actions (CAPA); and monitor effectiveness of implemented CAPAs
- Assess temporary and permanent changes from the manufacturing process and their impact on quality and regulatory compliance
- Provide guidance to the junior team member and conduct training
- Quality inspection of the cleanroom/manufacturing processes and provide on the floor QA support
- Participate in process improvement projects and proactively seek to improve and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times
- Support risk assessment activities
- Support Annual product quality review
- Perform other ad-hoc quality duties as requested by manager
- Degree and above in Cell biology/ Biotechnology/ Microbiology/Biomedical Science/ Biochemistry, Chemical Engineering, or Science related field.
- At least 3 years of working experience in quality assurance and/or compliance is preferred or with hands-on experience in cell therapy / Biologic product manufacturing GMP-regulated industries.
- cGMP experience with good working knowledge and understanding of biopharmaceutical manufacturing activities and regulations
- Change control experience and deviation is preferred
- Good understanding of quality management principles
- High attention to details
- Well organized and effectively manage multiple project
- Ability to identify problems, troubleshoot and complete or coordinate corrective actions
- Ability to communicate (both orally and written) effectively in professional manner with peers and management
- Good interpersonal and able to work with cross functional team collaboratively
- A positive attitude and an ability to adapt to, and embrace changed conditions
- For Senior role, change control and deviation experience is required