(Senior) Manager, Project Management

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

Job Position
(Senior) Manager, Project Management

Responsibilities

  • Support the execution of various CMC projects related to clinical pipeline programs.
  • Scope of activities includes the execution of CMC deliverables both short and long term via clearly defined milestones and schedule.
  • Responsible to organize and coordinate various activities amongst the Tessa technical 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.
    • Report project progress to all key stakeholders, escalating key issues and risks for the project.
    • Organize and coordinate deliverable from the various sub-teams, contractors, and vendors.
    • 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
  • Support the execution of various external manufacturing projects related to clinical pipeline programs. The candidate will lead a cross-functional team that is responsible for external manufacturing.
  • Scope of activities includes external cell therapy manufacturing, satellite laboratories for process, vector and cell bank manufacturing as well as potential collaborator transfers; the activities include:
    • Liaise with external contract development and manufacturing organization (CDMO) and partners related to pre-contractual, technology transfer and routine operations.
    • Serve as a point of contact for contractual issuance, quality issues and escalation of issues.
    • 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.

Requirements

  • Degree in Engineering or Biological Sciences, or other related field with at least 5 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.
  • Prior experience in cGMP Biologics facilities is a must.
  • Understanding of cell therapy or gene vector processes will be ideal.
  • Familiar with CDMO selection and contracting processes.
  • 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.
  • Travelling up to 15% may be required.