Work with cross-functional teams within the Process Development (PD) organization in executing projects in compliance with regulations and on time.
The projects can be Late Stage Development or Lifecycle Management projects.
The projects may include the development of drug substance, drug product, analytical test methods, and/or combination products.
Develop and maintain project schedules in close cooperation with project teams.
Support project teams to execute projects on time.
Support project teams in project execution by setting up teamwork tools (e.g. network sites and folders).
Establish and maintain project control tools and pro-actively monitor project progress.
Provide written and verbal project status updates to PD Senior Management.
The candidate should be a self-starter who can independently projects within PD.
The position will require flexibility and fast learning skills to adapt well in a dynamic environment with changing challenges.
Amgen develops differentiated, innovative medicines that meet important unmet medical needs.
The Sr. Project Manager (SPM) independently plans and manages the execution of development projects for Drug Substances and/or Drug Products.
The project responsibility starts at the end of Phase 1 studies and ends with the commercial launch. Usually the project scope includes the development / transfer of large scale manufacturing processes for DS and DP, as well as the development / transfer of analytical test methods, and occasionally the design and development of delivery devices.
Key responsibilities include:
Working closely with the team leads for Drug Substance (DS), Drug Product (DP), and Attribute Science (AS) to ensure projects are planned appropriately, executed in compliance with Amgen procedures, and completed on time within the resource constraints.
Developing detailed MS Project schedules which are based on input from the functional leaders and team members from DS, DP and AS and which reflect the dependencies of the individual tasks. Leveraging MS Project schedules to plan and manage the execution of the projects.
Partnering with the functional leaders to identify and manage risks, and ensure cross functional alignment and accountability throughout the entire project.
Communicating vertically and horizontally across many levels and functions within Amgen. Depending on the assigned project the SPM might work with Global Operations Leads, Regulatory Leads, Product Quality Leads, Product Delivery Teams, and other stakeholders.
Scheduling and moderating cross-functional team meetings and creating meeting minutes that are frequently distributed to SVP level management.
Establishing and/or managing collaboration and team sites (SharePoint, box, etc).
Establishing and maintaining project control tools and pro-actively monitoring project progress.
Additional responsibilities (depending on the assigned project):
Planning, preparing, and facilitating functional and cross-functional management reviews.
Providing guidance for project teams to identify the best approach to complete projects on time, to overcome obstacles, or to react to scope, resource, or timeline changes.
Traveling to other Amgen facilities or external partners as needed.
Required experiences and skills:
2+ years of hands-on Project Management experience with the development and/or manufacturing of drug substance and/or drug product within Biotechnology and/or Pharmaceutical industry.
Strong MS Project skills and experienced with MS Office.
Ability to self-start and independently manage product development projects within Biotechnology.
Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage activities from DS, DP, and AS simultaneously.
Ability to foster collaboration and work effectively on cross-functional teams.
Very good verbal and written communication skills as well as good interpersonal skills.
Strong analytical, critical thinking, and problem solving skills.
"This posting is for Contingent Worker, not an FTE"