Senior Manager, Equipment and Engineering (Drug Product Sterile Filling)

Company Background

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.

Job Position
Senior Manager, Equipment and Engineering (Drug Product Sterile Filling)

Job Description

  • 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

Requirements

  • 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