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 Manager, Equipment and Engineering (Drug Product Sterile Filling)
- Be the key point of contact for engineering matters within the fill finish production line
- Lead/ Support start-up activities, commissioning and handover of equipment & systems from project to users/ operation.
- Provide support for operations in terms of:
- Budgeting for maintenance and improvements
- Leadership for fill finish team
- Ensure target volumes are met by providing maximum equipment uptime
- Ensure that maintenance activities are carried out within schedule and according to site procedures
- Ensure the fill finish process line and facility is in a validated and compliant state (Quality and EHS)
- Lead/ support investigations, change controls and CAPAs
- Draft/ review/ approve GMP documents
- Diploma or Degree in an engineering discipline with minimum 10 years of working experience
- Prior experience with Fill finish equipment preferred but not a must
- Familiar with Microsoft project or other planning tools
- Experience in maintenance for pharmaceutical equipment is a must
- Experience in cGMP requirements is a must
- Advanced knowledge in electrical and instrumentation, mechanical and/or automation systems
- 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
- Willing to learn, self-starter and continuously improve
- Good communication and interpersonal skills
- Knowledge in Bio-Pharma R&D is an added advantage