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.
Associate Director / Director, Engineering, Facilities & EHS&S
- Tessa Therapeutics is looking for an innovative and motivated leader to build and develop the EHS&S, engineering and facilities capabilities to ensure compliance and operational activities related manufacturing or development are supported.
- Lead a diverse team to covering environmental, health and safety, automation, facilities and equipment support (e.g. in operating and maintaining various mechanical and electrical systems and services) in cell therapy manufacturing and development facility.
- Owns the system and execution of maintenance (both scheduled preventive and unscheduled breakdown), reliability engineering and calibration for all GMP-relevant equipment and utilities 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/redundancy to ensure timely seamless facility operations.
- Ensure the site’s facilities are kept to the highest standards for cGMP requirements, including fire safety, security, pest control, cleaning services and waste removal.
- Develop and sustain EHS&S management processes by the creation necessary procedures, training, 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.
- Operations include the biosafety assessment;
- Operations of irradiation equipment
- Guide team through the necessary investigations and ensure corresponding CAPAs are completed.
- Work with IT to establish and maintain MES and data warehouse automation systems for digital plant and process/business intelligence implementation
- Collaborate cross-functionally with manufacturing, MSAT, validation, quality and supply chain to meet customer needs, including quality, product and process requirements.
- Responsible for relevant project costing and annual budget preparation related to engineering, facilities and EHS.
- Provide guidance and training to the Facilities team to enhance the technical competency and industry knowledge as well as effectiveness of troubleshooting and problem solving.
- Development and coaching of managers and team
- Be an advocate for continuous improvement for more effective, efficient and cost-effective operations
- Be part of the site leadership team
- Degree or Masters in Chemical/Electrical / Mechanical / Mechatronics or equivalent engineering discipline.
- At least 10 years or more of facilities management, maintenance and / or equipment engineering or reliability experience preferably in large pharmaceutical or biological manufacturing environment (that in plant start-up would be advantageous), with at least 5 years of management experience.
- Possess strong technical competencies including MOM/NEA statutory requirements, reliability engineering, mechanical and electrical standards.
- Proficiency in calibration and preventive maintenance methodologies based on QbD approaches a must.
- Experience in cryo-storage and irradiation equipment 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.
- Strong ability to plan and prioritise activities (including across multiple projects) for self and team without supervision.
- Ability to communicate (both orally and written) effectively in professional manner with peers and management.
- Excellent interpersonal and leadership skills, ability to work cross-functionally.
- Excellent written and verbal communication skills.
- Self-motivated and able to work under pressure.