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Sr Manager, Process Dev Mgmt

Responsibilities

The successful candidate will direct the design, development and implementation of primary drug containers and injection tools. Technologies include cartridges for injection devices, pre-filled syringes, needle stick prevention devices and/or other novel injection tools and aids. Major responsibilities will entail component selection, assessment of container-device compatibility and container-drug compatibility, development of analytical methods to assess container quality and functionality for existing and new technologies. This person will lead the assessment, selection and implementation of new drug product configurations in collaboration with engineers and scientists in the He/she will provide guidance and input to project core teams and sub-teams in the area of primary containers and combination product development. This person will regularly interface with staff and leaders in Contract Manufacturing, Project Core Teams, Development, 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 may also supervise 2-3 staff.

Job Requirements

The ideal candidate will have an advanced degree in Engineering, Pharmaceutical Sciences or the equivalent. Experience in the Pharmaceutical, Biotech 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 working knowledge of manufacturing, quality control, preclinical and clinical development, and regulatory issues pertaining to combination products is preferred. A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable. Excellent communication skills are required. Experience in working with external companies is also highly desirable.


DIVISION:  Process Dev & New Manuf Facil
REQUISITION NUMBER:  09-1000028444 (SR. MANAGER DEVICE CONTAINERS)