The candidate will successfully manage three or more Drug Substance commercial technology transfers into B23 ATO.
Success will be measured by the technology transfers occurring in the timeframe required with limited to no issues that may impact program timelines or any planned budgetary constraints.
The project manager will be responsible for integrated activities from Operations, Process Development and Capital Projects and maintaining technology transfer project plans and schedules for commercial technology transfer.
This will include commercial Drug Substance manufacturing process transfers and integrating schedules for qualification of new equipment.
Working with the B23 operational leadership and the technology transfer steering committee, the Project Manager (PM) will align plans and schedules for activities with business priorities.
Additionally, the PM will ensure that key decisions that impact technology transfers are made at the appropriate time by the appropriate staff.
This will occur through a broad understanding of how the integrated team works together and by knowing when lower levels teams are not the appropriate place for the decision to be made.
The PM will assist in driving decision making for the technology transfers and will ensure that action items are captured and tracked to completion.
The PM will also partner functional area technical leads to identify key deliverables and activities to be completed by the 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.
In addition, will assist the technical leads with tracking the completion of required technical deliverables via dashboards and reporting on project metrics on a routine basis.
Support commercial technology transfers that utilize multiple organizations for activities and deliverables
Support product programs utilizing structured, systematic methodologies to meet cost and schedule objectives.
Follow Amgen’s governance processes, procedures, specifications and applicable compliance standards and guidance documents.
Integrate Operations, Process Development and Capital Project activities by developing and maintaining detailed project schedules for Amgen Drug Substance Technology transfers.
Partner with technology transfer functional leads to identify key deliverables and ensure cross functional alignment and accountability.
Negotiate and resolve conflicts and drive decisions among team/functional members to accomplish project and business goals.
Assist 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 Online).
Manage and prioritize support of multiple project teams at one time.
Provide meeting facilitation, including development of meeting agenda and minutes.
Accurately and actively capture and monitor status of action items through effective tracking tools and communication of progress.
Track delivery and create repositories for all deliverables.
Facilitate and incorporate lessons learned, best practices, etc.
Project reporting including appropriate risk analysis
"This posting is for Contingent Worker, not an FTE"