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.
Interact with cross-functional groups and external partners to develop project scope & objectives, resource requirements, and detailed project schedules.
Provide leadership to cross-functional project teams (R&D, Process Development, Site Operations, Technical Services and QA/QC, and Regulatory Affairs) to adhere to key project timeline milestones, risk management analysis, key transfer dates and overall project and business goals.
Responsible for the development of project timelines in collaboration with R&D, Operations, QC, RA and external partners, and responsible for holding them accountable for delivery.
Identify critical paths and barriers. Deliver implementation strategies and resolve issues impacting them. Proactively manage projects, anticipating issues and potential delays to achieve on-time completion.
Organize and lead regular project review meetings with cross-functional departments.
Interacts, through program updates and review, with all levels of management.
Responsible for maintaining the project risk register and for making decisions regarding the appropriate risk when there is substantial project impact.
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.
B.S. in Science (Chemistry, Pharmacy, Biology, Microbiology or related sciences) is required.
Minimum of 5-7 years of progressive cross-functional project management experience is required with a focus on pharmaceutical products.
Experience managing external partners (strategic partners, CROs, CMOs). Experience with dosing devices and clinical studies is desired.
2 openings. Employer will assist with relocation costs.
Additional Salary Information: 6% 401k match, salary and bonus commensurate to experience
About West-Ward Pharmaceuticals
West-Ward Pharmaceuticals is one of the top generic prescription medication providers in the US offering oral solid and injectable pharmaceuticals to through a comprehensive supply chain. We are the US agent and subsidiary of the FTSE-100 listed Hikma Pharmaceuticals PLC. The Bedford Development Center, (BDC) located in Northeast Ohio is West-Ward’s Research and Development Center of Excellence for injectable products. The facility is equipped with state of the art product and analytical development equipment and is run by a highly skilled staff with experience spanning a number of injectable formulation platforms including liposomes and nanoparticules. The center is supported by a strong regulatory affairs group that supports regulatory filings.