Responsible for developing and maintaining project plans and schedules for life cycle projects which may include new formulations, new manufacturing processes, process transfers and new delivery devices.
Working with the Global Operations Leader and other members of the Product Delivery Team, the Project Manager will ensure that plans and schedules for Process Development activities are aligned with business priorities.
The role will ensure that associated project risks are captured, mitigation plans are developed and status is clearly communicated to impacted stakeholders.
The PM will assist in driving timely decision making for the project and will ensure that action items are captured and tracked to completion. Partner with process development technical leads to identify key deliverables and activities to be completed by functional teams.
This will include identification of dependencies and optimizing the sequence of activities.
The Project Manager will ensure cross functional alignment and integration of interdependent activities via cross functional communication of plans and timeline with specific emphasis on critical path activities. Assist the technical leads with tracking the completion of required technical deliverables via dashboards and reporting on project metrics.
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
Follow Amgen’s governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents
Responsible for integrating Process Development activities by developing and maintaining detailed project schedules for Amgen pipeline and biosimilar projects.
The Project Manager will partner with Process Development functional leads to identify key deliverables and will ensure cross functional alignment and accountability.
Negotiate and resolve conflicts and drive decisions among team/functional members to accomplish project and business goals
Assist the Process Development Organization in driving decisions by using the Decision Making Framework (D- Decision maker, A- Advice Giver, I- Informed)
Ensure participation in functional and cross-functional management reviews
Establish and manage collaboration and team sites (e.g. SharePoint)
Manage and prioritize support of multiple project teams at one time
Provide meeting facilitation, including development of meeting agenda and minutes
Accurately capture and monitoring status of action items through effective tracking tools and communication of progress
Track delivery and create repositories for all Process Development deliverables
Facilitate and incorporate lessons learned, best practices, etc.
Support Business Process improvements, including alignment with Chemistry, Manufacturing, and Controls excellence (CMCX)
Deep understanding of and experience with disciplined product development processes (phase/gate product development method)
Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes
Experienced in creating and maintaining a Design History File
Project reporting including appropriate risk analysis
Proven ability to manage in a highly fluid, interactive, matrixed environment
Experience with MS Office, Project, Excel and SharePoint
20% travel domestic and international
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics.
Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.
Reporting into the Program Management Office within the Operations Late Stage/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 delivery devices that are integrated with biologics to create drug/device combination products.
Doctorate degree & 2 years of Project Management experience OR Master’s degree & 3 years of Project Management experience OR Bachelor’s degree or & 5 years of Project Management experience OR Associate’s degree & 8 years of Project Management experience OR High school diploma / GED & 12 years of Project Management experience
5 years+ of project management experience in the Pharmaceutical, Biotechnology or Medical Device related field, direct CMC experience is highly desirable
Experience successfully developing and launching commercially viable pharmaceutical or combination drug/device products from concept to commercialization
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
Experience with performing critical path analysis
Critical thinking and problem solving skills
Quick learner, proactive, takes initiative
Distinguishes proper balance between strategic and tactical thinking
Strong experience with Project Management tools, methodologies, and practices
Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analysis and influence decision-making
"This posting is for Contingent Worker, not an FTE"