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 Quality team.
- Work closely with a technical team to provide facilities and equipment support (e.g. in operating and maintaining various mechanical and electrical systems and services) in cell therapy manufacturing facility.
- Owns maintenance (both scheduled preventive and unscheduled breakdown) and calibration for all GMP-relevant equipment used in cell therapy production and testing, including that of the associated contracts with maintenance / calibration vendors. Ensure all equipment performance is monitored, trended and recorded for continuous improvement and reliability.
- Responsible for planning and execution of MRO requirements as well as service contracts for spares to ensure timely seamless facility operations.
- Develop and sustain the site’s Facilities and EHS management processes. Create necessary procedures, work instructions (including those on emergency response and disaster recovery management) and ensure all related projects are carried out in accordance to industry standards and regulatory / statutory guidelines.
- Responsible for liaising with government authorities on all permits and licensing matters related to EHS matters
- Contracts and supervises facility housekeeping to ensure a safe, clean, and cGMP-compliant facility, including pest control and waste removal management.
- Participate in necessary investigations and ensure corresponding CAPAs are completed.
- Responsible for relevant project costing and annual budget preparation related to Facilities and EHS.
- Provide guidance and training to the Facilities team in order to enhance the technical competency and industry knowledge as well as effectiveness of troubleshooting and problem solving.
- Degree in Electrical / Mechanical / Mechatronics or equivalent engineering discipline.
- 6 years or more of Facilities management, maintenance and / or equipment engineering experience preferably in large pharmaceutical or manufacturing environment (experience in plant start-up would be advantageous), with at least 3 years in a supervisory position.
- Hands-on and possess strong technical competencies with good knowledge of mechanical and / or electrical systems.
- Be able to read and understand mechanical engineering drawings and electrical / electronic schematics.
- Knowledge of SAP and Blue mountain RAM software preferred.
- Proficiency in calibration and preventive maintenance methodologies based on QbD approaches a must.
- Experience in cryo-storage facilities desirable
- Knowledge of the industry-relevant standards, e.g. ISO 14001, OHSAS 18001, Safety Management System (MOM), etc. will be an advantage.
- Demonstrated ability to work proactively to identify issues, perform analyses and propose solutions; and to design and implement effective systems, processes and information / reporting mechanisms.
- Possess good people management skills.
- Excellent interpersonal and leadership skills, ability to work cross-functionally.
- Excellent written and verbal communication skills.
- Self-motivated and able to work under pressure.