The role includes leading cross-functional teams to manage the flawless execution of tech transfers to our contract manufacturing network and will include partnering with Contract Manufacturing Organizations as well. There will be some travel involved with this role, circa 20%, travel to CMOs across Europe
* Manage multiple cross-functional TT projects of medium to high complexity to CMOs and ensure adherence to ACM tech transfer business process
* Oversee the activities of all operations aspects involved in Technology Transfer to CMOs to ensure a robust transfer.
* Partner with cross functional team, manage TT related meetings, escalations and drive decision making
* Coordinate creation/update of TT related documents
* Partner with legal and GSS to create/negotiate TT related contracts
* Manage PO/invoices requests/approvals
* Project management of resource planning, generating metrics/ KPIs and presentation materials for management reviews and governance meetings
* Enhance process alignment and driving strategic discussions in ACM management and among the ACM site teams.
* Lead of technical change controls for NPI (new product introduction)
* Responsible for building project plans and team assignments using Gantt charts in MS Project, estimating project cost and adhering to budget, directing and monitoring work efforts on a daily basis, identifying resource needs, performing business quality reviews, and escalating functional, quality, timeline and cost issues appropriately.
* Utilize project management processes, software and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
* Accountable and responsible for adhering to project cost and timeline
* Coordinate communication with all areas of the enterprise that impact scope, budget, risk and resources of the work being managed
* Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within Amgen. Apply the knowledge, skills, tools of project management / operational excellence (OE) to ensure optimal execution of projects, identity potential savings and continuous improvement initiatives
* Master's degree and 2 years of Project Management experience (Tech Transfer, pharma/biotech) OR
Bachelor's degree and 4 years of Project Management experience (Tech Transfer, pharma/biotech)
* 2 years leading medium to complex projects. (pharma/biotech, ideally small molecule)
* Extensive knowledge and expertise in the use of project management methodologies and tools, resource management practices and change management techniques
* Understanding international pharmaceutical industry landscape and business principles
* Experience in small molecule tech transfers preferred
* Strong analytical skills and knowledge of analytical tools within MS Excel, Smartsheet, ThinkCell, and other software programs
* Green Belt or Black Belt certification
* 1+ year of experience in Lean Manufacturing or Operational Excellence
* MBA or business operations degree or equivalent experience in business/operations management
* GMP environment work experience and thorough understanding of biological/chemistry technology transfer processes and timelines
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.