Reporting into the Program Management Office within the Process Development Late-Stage and Life Cycle Management (LCM) organization, this role will support cross-functional teams from multiple Amgen sites, functions and external partners, to develop innovative drug products and/or drug/device combination products.
The Project Manager (PM) is responsible for integrated Process Development (PD) activities by developing and maintaining technical project plans and schedules for late-stage and lifecycle projects which may include commercial PD activities, clinical manufacturing, analytical development, commercial process development, process characterization and validation, new formulations, new manufacturing processes, process and technology transfers and new or platform drug delivery devices. Working with the Global Operations Leader and other members of the Product Delivery Team, the PM develops and aligns plans and schedules for PD activities with business priorities. The PM captures associated project risks, develops mitigation plans and communicates project status clearly to impacted stakeholders. The PM assists with driving decision making for the project and ensures that action items are captured and tracked to completion. The PM partners with PD technical leads to identify key deliverables and activities to be completed, identifies dependencies, and optimizes the sequence of project activities. The PM ensures cross-functional alignment through the integration of interdependent activities and through the communication of plans and timelines, with specific emphasis on critical path activities. The PM assists PD technical leads with tracking the execution of required deliverables and assists with navigating project teams through corporate governance. The PM collect, digest and assemble information in order to enable relevant business analysis and influence decision-making. The PM will leverage soft skills, technical knowledge, and leadership attributes in order to influence positive project outcomes.
Responsibilities include but are not limited to:
*Support projects that utilize internal and external personnel, contract firms, and partners
*Support combination product development programs utilizing structured, systematic methodologies to meet cost and schedule objectives
*Develop and manage PD activities in an integrative fashion via detailed project schedules for Amgen pipeline, inline, and biosimilar projects encompassing cross-functional scope of work
*Partner with PD functional leads to identify key deliverables and ensure cross functional alignment and accountability
*Drive negotiation, decision making, and conflict resolution among team/functional members to accomplish project and business goals
*Assist the PD Organization in driving decisions by using the Decision Making Framework (D- Decision maker, A- Advice Giver, I- Informed)
*Establish and manage collaboration and team sites (e.g. SharePoint)
*Manage and prioritize support of multiple project teams at one time
*Provide meeting management support including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and outcomes communication
*Project reporting including appropriate risk analysis
20% travel domestic and international
Master's degree and 2 years of Project Management, Process Development or Operations experience
Bachelor's degree and 4 years of Project Management, Process Development or Operations experience
Associate's degree and 10 years of Project Management, Process Development or Operations experience
High school diploma / GED and 12 years of Project Management, Process Development or Operations experience
5 years of project management experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, direct CMC or PD PM experience.
Understanding of and experience with product development processes
Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time.
Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills.
Proven ability to manage in a highly fluid, interactive, matrix environment.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.