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Intertwined

Pharmaceutical MS&T Director (paid re-lo to Baltimore Area)

Full Time
Dallas, TX, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with a Global Pharmaceutical leader based in Maryland, on their quest for a talented Pharmaceutical MS&T Director. In this role, you will oversee several engineers, scientists, analytical and technical professionals for GMP aseptic drug product formulation, from a conceptual idea to filling and primary packaging for liquid, lyophilized and suspension products.  


Responsibilities

  • Lead a team in technical assessment of new product opportunities.

  • Team management, including hiring and employee development.

  • Introduce and transfer products to the site.

  • Manage and drive continuous improvement for the MS&T operations.

  • Formulate and align strategy for plans an operations.

  • Manage resources and MS&T resourcing solutions.

  • Serve the system owners of multiple quality systems including media fill, analytical method validation, and Product Process Qualification (PPQ).

  • Manage Technical Project Managers, and the Technology Transfer Analytics and Process resources.

  • Plan and manage department budget, including program and project costs for MS&T.

  • Oversee, project, program and portfolio performance.

  • Oversight of system owners for technology transfer, process validation and method validation systems 

  • Ensure and maintain inspection readiness for each of the systems 


Requirements
  • Relevant BS degree, at minimum.

  • 10+ years’ GMP aseptic drug product manufacturing experience.

  • Strong management of scientists and engineers. Must be an engaging leader able to change the status quo and drive quality procedures, culture and change in complex environments.

  • Strong experience with GMP Pharma Aseptic fill/finish.

  • Understanding of MS&T concepts regarding pharma drug process development and improvement.




MS&T, quality, QbD, GMP, program, project, director, manager, materials science technology, MSAT

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