Pharmaceutical MS&T Director
Baltimore, MD, USA
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.
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
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 firstname.lastname@example.org
MS&T, quality, QbD, GMP, program, project, director, manager, materials science technology