Intertwined

Pharmaceutical MS&T Director

Full Time
Baltimore, MD, 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 manufacturing experience encompassing the below aspects.

  • Experience managing scientists/engineers.

  • Strong knowledge and implementation of lean & QbD principles.

  • Experience conducting site strategic planning and prioritization.

  • Experience with cross-functional project planning and execution.

  • Strong risk management and technical knowledge.

  • Understanding of MS&T concepts, including Formulation Development, Process Development, Product Process Improvement, QbD.

  • Experience with Process and Analytical Method development and validation, as well as media fill.

  • Quality Systems experience.


To apply please send your application to mschroeder@thedenzelgroup.com


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

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