IPD Project Manager/Planner
San Mateo Metro Area, CA
A member of the Inhalation Product Development Team in California (IPD-CA) engaged in supporting project teams and project leaders through late stage clinical and technology transfer projects. The candidate who fills this position will be expected to support project and resource planning as it relates to timelines, equipment and manufacturing scheduling, supply chain, RBUs, and capacity extrapolations. They will engage with key functions in Development, Operations, Commercial and Finance and where appropriate, partnering companies to drive project productivity and timelines.
In conjunction with project leader, support pharmaceutical and device development projects through the development process of feasibility through early clinical phase development/production.
In conjunction with functional lead, manage production schedules, equipment and resources as they pertain to production demands and forecasting
Responsible for supporting CMC project teams in the development, validation and ongoing planning and control of the integrated CMC project plans including activity durations, resource and dollar forecasts and risks associated with the defined activities
Accountable for ensuring that the project team members from PhSci and PhDev functions contribute to and receive valuable feedback on the team s project plans, forecasts and information.
Pro-actively monitors key parameters (assumptions/risks/ time and costs) , manages critical path and responsible to flag any deviation
Support the financial aspects of the projects (i.e., creating and managing budgets, setting up vendor contracts and Purchase Orders, tracking invoices, and accruals)
Support in managing team meetings (agendas, action items, status reports)
Support in vendor management
BA/BS Degree in a relevant science discipline; a higher degree preferred with a minimum of 5 years of experience in drug development within the pharmaceutical industry.
CMC design, development and technical support experience from phase I to late stage development and/or post launch phases
In depth knowledge of project management as a discipline including the ability to create, coordinate, and maintain an integrated product plan and to control or respond to changes in strategy and scope.
Understanding financial and resource planning systems and processes and ability to coordinate project-level budget/resource estimates and manage actuals vs. plan.
Preferable inhalation product development, clinical/commercial supply chain, regulatory experience with ideally good knowledge of the broader business especially development, commercialization, post-launch technical support and lifecycle management
Demonstrated strong interpersonal and communication skills (credible and persuasive)
Proactive, forward-thinking and creative with high ethical standards and a team player with leadership skills and ability to influence others to achieve successful outcomes and meet timelines
Familiarity with domestic and international cGMP regulations and industrial guidance documents (CFRs, ICH)
Self-motivated and willing to accept responsibilities outside of initial job description
Ability to handle multiple project and priorities with exceptional organizational, attention to detail and time management skills