GMP Process Development Director

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