Job Type: Contract
Job ID: JO-1908-19238
Consultant: Karen McHugh
Do you have 2+ years experience leading medium to complex projects, ideally in the BioPharma industry? Have you demonstrated expertise in the use of project management methodologies and tools, resource management practices and change management techniques?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Project Manager - Biotech NPI - Dun Laoghaire - Dublin
Our Client is Amgen and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
As part of the Amgen Contract Manufacturing (ACM) Business Operations and Strategy team, the Project Manager will be responsible for managing all aspects of key initiatives and projects in the ACM network of functions, which includes Operations, Supply Chain, Quality, Process Development, Finance and Legal.
There will be some travel involved with this role, circa 20%, travel to CMOs across Europe
These activities may include analyzing opportunities, project scoping and chartering, project strategy, process mapping and definition, process improvement and re-engineering and change management activities.
In addition, the Project Manager will be responsible to align and integrate the ACM performance management processes and systems across the organization and advance our culture of Operational Excellence.
The role includes leading cross-functional teams to support the development of consistent, robust processes and systems to ensure quality and supply reliability with our contract manufacturing network and may include partnering with Contract Manufacturing Organizations as well.
Standardization and continuous improvement is a primary focus for this role.
Contract Manufacturing’s strategy is to reach lean stability as soon as practical and embody continuous improvement to mature the lean culture.
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)
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
Willingness to travel to CMOs across Europe
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
Keen financial acumen and knowledge of the end-to-end financial
Strong quantitative and analytical skills
Demonstrated ability to work and lead effectively in collaborative/team environment
Demonstrated ability to take initiative and act independently
Excellent interpersonal and verbal communication skills
Excellent writing skills
Ability to work in a fast paced, dynamic environment
Aptitude to think strategically
Hourly Rate €45- €53 per hour
Minimum contract duration: 12 months
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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