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Assoc Dir, Process Dev Mgmt

Responsibilities

The successful candidate will lead a group of scientists and engineers to develop and commercialize injection devices for Genentech's therapeutic proteins in conjunction with external partners.  Injection devices may include pens, auto-injectors and/or other delivery devices.  Major responsibilities will include technical oversight for all phases of design, industrialization, and commercialization of the delivery devices, including work conducted by external development partners and component suppliers.  He/she will provide guidance and input to project core teams and sub-teams in the area of device and combination product development, including integration with the full spectrum of drug development activities.  He/she will serve as key resource and 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 device, combination product and/or pharmaceutical development. The candidate must have deep expertise in delivery device design, development, industrialization, and commercialization, combined with a broad knowledge of manufacturing, quality control, preclinical and clinical development, and regulatory issues pertaining to delivery devices and combination products. The candidate must have a proven track record of taking delivery devices and/or combination products from conception to successful implementation and commercialization. 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:  09-1000027514 (DEVICE DEVELOPMENT)