Senior Project Manager

As a member of the Process Development organization, this role serves as project manager for Final Drug Product New Process Introductions (NPI).

NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.

The Project Manager engages Final Drug Product development teams throughout the commercialization process, leading cross-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.

Responsibilities:

Assessment of NPIâ s for necessary process, facility, equipment, materials, and training modifications

Development of project execution plans; ensuring process requirements are effectively transferred into manufacturing;

Coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification)

Supporting manufacturing readiness activities. Basic Qualifications

Doctorate degree and 3 years of experience OR Masters degree and 5 years of experience OR Bachelors degree and 7 years of experience OR Associates degree and 12 years of experience OR High school diploma / GED and 14 years of experience

Technical project management

Communication

Problem solving skills