BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Reporting to the Senior Director of the MSAT function within Global External Operations, the Associate Director, Medical Device & Combination Products, is responsible for the technical leadership related to commercial/clinical Medical Device and Combination Product activities globally. They will manage a team that leads development and delivery of devices for relevant BioMarin products, including but not limited to; device development and design history, technology transfers into our contract manufacturers as well as our internal manufacturing sites, management of the technical relationship with key external vendors, device project management, product complaint management and product lifecycle management.
This position provides strong leadership for all aspects of Medical Device & Combination Products manufacturing at CMO’s and internally.