Associate Director / Senior Manager, External Manufacturing Operations

Company Background

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created 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.

Job Position
Associate Director / Senior Manager, External Manufacturing Operations

Reports To
Senior Director, Process, Science & Technology

Responsibilities

  • The candidate will support the execution various external manufacturing projects related to clinical pipeline programs. The candidate will lead a cross-functional team that is responsible for external manufacturing.
  • The scope of activities includes external cell therapy manufacturing, satellite laboratories for process, vector and cell bank manufacturing as well as potential collaborator transfers.
  • The phases of activities will include:
    • Lead the selection, contracting, setup and operational liaising of external contract manufacturing organizations (CMOs).
    • Serve as a point of contact for contractual issuance, quality issues and escalation of issues.
    • Support technology transfer of processes where required. Potentially lead the activity depending on the scale and complexity
    • Ensure the qualification or acceptance of manufacturing activities where required before moving into the operational phase
    • Monitor operations, ensuring systems are synchronized between satellite laboratories and external manufacturing sites.
    • Ramp down and closure of projects to ensure proper procedures are adhered to and contracts closed out, including transfer of necessary intellectual property, operational data or quality documents.Be part of and help nurture an environment where individuals and teams can grow and excel.
  • The individual will organize and coordinate various activities amongst the Tessa functions including:
    • Ensures necessary communication within the project team (meetings, reporting) and coordinates interfaces outside of the project team with core team members, steering team members and stakeholders.
    • Responsible for joint steering team for meeting project objectives
    • Report project progress to all key stakeholders, escalating key issues and risks for the project.
    • Supports the technical team to investigate any project challenges with necessary risk assessment tools and techniques then implements corrective measures
    • Evaluates and assesses project results and provides recommendations for future improvement as part of a continuous improvement effort
    • Closely monitor/control project progression to ensure projects are completed on schedule and within budget
  • Be part of and help nurture an environment where individuals and teams can grow and excel.

Requirements

  • Degree in Engineering or Biological Sciences any related field with at least 10 years of relevant working experience in technical project management, operations with contract development or manufacturing organizations (CDMOs) or collaboration partners.
  • Technology transfer and/or early clinical stage program experience is required
  • Able to juggle 2 or more programs simultaneously, depending on complexity and size of trial
  • Understanding of cell therapy or gene vector processes ideal.
  • Prior experience in cGMP Biologics facilities, quality assurance and working with contract organization and vendors a must.
  • Proactive in working on solving issues and problems
  • Able to work in a matrix environment and handle ambiguity
  • Able to communicate with impact, ensuring alignment and negotiating positive outcomes from various stakeholders.
  • Familiar with CMO selection and contracting processes
  • Comply to Tess safety practices and standard operating procedures
  • Exhibit and promote Tessa’s Core Values
  • Travelling up to 15% may be required