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Assoc Dir, Process Dev Mgmt

Responsibilities

The successful candidate will lead a group of scientists and engineers to develop and provide technical commercial support for primary drug containers and injection tools.  Technologies include cartridges for injection devices, pre-filled syringes, needle stick prevention devices and other injection tools and aids.  Major responsibilities will include technical oversight of development projects for primary containers and injection handing devices and tools.  Oversight includes work conducted by external development partners and component suppliers.  The incumbent will provide guidance and input to project core teams and sub-teams in the area of primary containers and combination product development.  He/she serve will provide input into Marketing, Operations, Development and Regulatory strategy for Combination Product projects.  This person will regularly interface with staff and leaders in Manufacturing Collaborations, Project Core Teams, Marketing, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs.  He/she will also regularly interact with external development partners and component suppliers.  He/she will also provide input to efforts to develop business processes for combination products.


Job Requirements

The ideal candidate will have a Ph.D. in Engineering, Pharmaceutical Sciences or the equivalent.  Experience in the Pharmaceutical or Medical Device industry is required, with at least 10 years of experience in primary container, combination products, or biopharmaceutical development. The candidate must have deep expertise in primary container materials, drug-container compatibility, container-device compatibility and/or injection devices. A broad knowledge of manufacturing, quality control, preclinical and clinical development, and regulatory issues pertaining to combination products is essential.  He/she must have experience managing groups of engineers and scientists.  A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable. Excellent people management, communication, and influencing skills are required.  Experience in managing partnerships with external companies is also highly desirable.


DIVISION:  Process Dev & New Manuf Facil
REQUISITION NUMBER:  09-1000027651