Senior Director, Program Lead (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 Director, Program Lead (Drug Product Sterile Filling)

Overview

As a Program Lead (Drug Product Sterile Filling), you will work in an environment where you can:

  • Be the business process owner in its specified domain, being responsible for the governance of contract Fill and Finish services, process performance & process changes
  • Accelerate value creation and ensure harmonization with product sponsor or customer as well as internal stakeholders on the portfolio (project/suite will function as a Contract Manufacturing Organization (CMO))
  • Deliver the Drug Product on time and with the required quality

Responsibilities

Process ownership:

  • Bring simplicity and alignment across Technical Operations to enhance performance and compliance of business processes.
  • Perform maturity assessment of business processes versus corporate standard and lead improvement project.
  • Foster collaboration across its manufacturing network to develop harmonized business processes and tools related to manufacturing support and manufacturing innovation.
  • Identify and lead implementation of global processes and systems to standardize best practices across locations.
  • Start-up project portfolio and project leadership:
  • Oversee the build out and start-up of a fill and finish manufacturing suite by directly leading project manager, schedules, budgets, and the reporting of all related activities.
  • Drive projects, develop and implement initiatives to continuously improve manufacturing capabilities and provide effective cross-functional collaborations and communications.

Lead Manufacturing Excellence:

  • Build a sustainable manufacturing operation as a CMO.
  • Fostering an environment of innovation, collaboration, continuous improvement, and people engagement.
  • Provide “technical” leadership and expertise to the manufacturing network in its specified domain.
  • Contribute to develop the Tessa’s community knowledge in its related domain by sharing benchmark, outside-in, lesson learned and drive improvement initiatives.
  • Ensure harmonized interpretation of regulatory changes and its implementation.
  • Share innovation, best practices, and benchmark for the manufacturing network in collaboration with the related community.
  • Support complex trouble shooting, product impact assessments and process/product improvement activities in its specified domain manufacturing network.
  • Represent the company in industry consortiums and coordinate associated activities.
  • Identify project risks and implement risk reduction plans.
  • Provide knowledgeable support for audit or due diligence for its related domain.

 

Requirements

  • Bachelor’s degree in Biotechnology/ Biosciences/ Engineering or equivalent; an advance degree desirable
  • 8-10 years of management experience and/or in 15-20 years in Operational Drug Product & Packaging within the Biologics or Vaccine Industry
  • Knowledge of Operational Excellence, Lean and Six Sigma
  • Operations in Contract Manufacturing Operations desirable
  • Confirmed practice on project management, coaching and training
  • Experience in process definition and implementation, as well as in change management is a strong asset
  • Strong orientation toward end-to-end process performance
  • Good command of MS Office tools, portfolio, and project management IT systems
  • Travel 5-10% to customer site as required

Soft Skills

  • Leadership skills
  • Knowledge of organization’s culture and structure
  • Broad understanding of interdependencies between functions and the associated cause-and-effect relationship
  • Ability to establish and govern manufacturing business process towards excellence performance
  • Ability to facilitate business process by listening, monitoring, and involving other members of staff towards attaining business goal
  • Ability to benchmark and analyze various business processes
  • Flexibility, tolerance, and diplomacy to best manage change and differing opinions
  • Ability to work in a virtual setting/across time-zones, i.e., making effective use of communication tools
  • Ability to work in a highly complex, multi-cultural, environment