Responsibilities
- 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 manage
- 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
Qualifications & Experience:
- Doctorate degree (maybe in chemistry, but industry experience preferred), Master’s degree and 2 years of Project Management experience (Tech Transfer, pharma/biotech),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
If interested please contact Sean on 021-4297900 or sena.molloy@peglobal.net
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