Senior Director, Program Lead (Drug Product Sterile Filling)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on cancer treatment through the development of autologous and allogeneic cell therapies for a range of cancers.

Our portfolio of next-generation therapies is derived from two innovative technologies: CD30-Chimeric Antigen Receptors (CD30-CARs) and a specific subset of T cells known as Virus-Specific T Cells (VSTs). We are also developing a novel, allogeneic platform technology that combines the unique properties of CD30-CARs and VSTs. This platform anchors our 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, expected to be ready in 2021, will substantially enhance in-house production capabilities and ensure that patients can benefit from our cell therapies more rapidly.

Patients are at the heart of what we do. Our mission is to change cancer treatment and give patients a new lease on life. We are looking for team members who have a passion for creating breakthroughs in cancer treatment. We want to work with people who seek to go beyond, and to pioneer new innovations. You can find out more about our company by visiting our website: www.tessatherapeutics.com.

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

Reports To
Chief Operating Officer

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

  1. 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.
  1. 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