Senior Director Sterile Fill/Finish
volt
Singapore
6d ago

Responsibilities

  • Assume responsibility 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
  • 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
  • Oversee the build out and start-up of a fill and finish manufacturing suite directly leading project manager, schedules, budgets and the reporting of all related activities.
  • Build a sustainable manufacturing operation as a contract manufacturing organization, fostering an environment of innovation, collaboration, continuous improvement, and people engagement.
  • Provide technical leadership and expertise to the manufacturing network in its specified domain.
  • 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.
  • Identify project risks and implement risk reduction plans.
  • Provide knowledgeable support for audit or due diligence for its related domain.
  • Requirements :

  • Advanced degree in biotechnology, biosciences, engineering or equivalent with at least 15-20 years experience in Drug Product and Packaging within Biologics / OSD / Vaccine
  • Knowledge of Operational Excellence, Lean and Six Sigma.
  • Operations in Contract Manufacturing Operations
  • Confirmed practice on project management, coaching and training.
  • Experience in process definition and implementation, as well as in change management
  • Broad understanding of interdependencies between functions and the associated cause-and-effect relationship
  • Ability to benchmark and analyze various business processes
  • Flexibility, tolerance, and diplomacy to best manage change and differing opinions
  • Ability to work in a highly complex, multi-cultural, environment
  • Travel 5-10% to customer sites as required
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