Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.
Tessa’s clinical pipeline derives from two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.
Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.
Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.
Senior/ Lead Equipment Engineer (Drug Product Sterile Filling)
- Support start-up activities, commissioning and handover of equipment & systems from project to users/ operation.
- Provide operational support in terms of the following:
- Reliability and maintenance of process equipment for Fill and Finish line
- Support product yield improvement projects
- Ensure maximum machine uptime
- Lead/ support investigations, change controls and CAPAs
- Draft/ review/ approve GMP documents
- Manage external contractors in the areas of System, Equipment and Rooms for Calibration and Maintenance
- Ensure maintenance and service contracts are executed as per requirements; establish regular review points with external contractors as required to continually improve processes and performance
- Ensure that work carried out on site adheres to site EHS and quality procedures
- Work cross functionally to ensure Systems, Equipment and Rooms meet Internal Customers’ needs
- Advocate and support EHS initiatives
- Diploma or Degree in an engineering discipline with minimum 7 years of working experience
- Prior experience with Fill and Finish equipment will be a plus
- Familiar with Microsoft project or other planning tools
- Able to work in a multi-cultural, fast-paced environment with minimum guidance
- Has prior experience leading teams but is also able to leverage on cross functional support
- Experience managing both internal and external stakeholders
- At least 5 years of relevant experience in managing contractors in cGMP facility operations
- Experience in cGMP requirements is a must
- Willing to learn, self-starter and continuously improve
- Good communication and interpersonal skills
- Knowledge in Bio-Pharma R&D is an added advantage