Senior Manager/ Manager, Automation (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/ Manager, Automation (Drug Product Sterile Filling)

 Job Description

  • Custodian and technical stewardship for automation related systems
  • Drafting/ review/ approval of SOPs, WPs, and other quality related documents for automation
  • Support maintenance shutdown activities
  • SME for automation systems during regulatory inspection
  • Lead/ Support Capex improvement projects
  • Human and financial resource planning
  • Lead/ support EHS best practices
  • Provide support for site automation:
    • Lead/ support CMs and PMs for automation systems
    • Managing stakeholders across various functions and externally
    • Integrating project timelines into Tessa’s drug development program

Requirements

  • Diploma or Degree in an engineering discipline with minimum 10 years of working experience
  • At least 5 years of relevant experience in managing contractors in cGMP facility operations
  • Experience in cGMP requirements is a must
  • Well versed in PLC and SCADA platforms like Allen Bradley/ Rockwell, Siemens, and Schneider
  • Well versed with automation protocols like Modbus RTU/TCP, Profibus DP/PA, Profinet, SQL, OPC, etc.
  • Working knowledge of computer networks
  • Well connected with technology and markets trends for Automation & IT
  • Knowledge in Bio-Pharma R&D is an added advantage
  • Able to work in a multi-cultural, fast-paced environment with little guidance
  • Has prior experience leading teams but is also able to leverage on cross functional support with less direct reports
  • Experience managing both internal and external stakeholders
  • Willing to learn, self-starter and continuously improve
  • Good communication and interpersonal skills
  • Comply to Tessa safety practices and standard operating procedures