GMP Process Development 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 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