The Project Manager provides business and technical leadership for the development and site transfer (internal or external) of injectable pharmaceutical products. The Project Manager is accountable for overall project performance including, integration of project activities and project resources, risk mitigation and management as well as serving as the liaison for senior management, R&D, Operations, and other stakeholders, such as strategic partners. They will establish and lead cross-functional teams and provide input to the program prioritization process. The Project Manager will make transfer readiness commitments to the sites and leadership team as well as manage stakeholder expectations with regards to deliverables during execution.
Must have a technical background, preferably in pharmaceuticals and R&D/Quality Control.
Must have experience managing external partners (Strategic Partners, CROs, CMOs). Experience with dosing devices and clinical studies is desired.
Must be well versed in Project Management tools, and must possess knowledge of related disciplines.
Must have knowledge of such principles as cGMPs, FDA guidelines, clinical studies and industry practices.
Must be self-motivated, have good interpersonal skills, be capable of analyzing and solving complex problems through innovative thought and experience, and be able to manage and resolve conflict.
Must demonstrate strategic and global cross-functional leadership.
Must have excellent communication and organizational skills
Education and/or Experience: