Project Lead

Please note: Required to use personal laptop for work, as the client will not be supplying any equipment.

This role is remote.
Part time - 20 hours per week


The Project Lead, Devices has responsibility for the overall performance of the CMOs and critical suppliers within their portfolio.
They achieve this by applying a number of guiding principles:
i. Reliability of the CDMO/supplier to deliver on supply or project commitments
ii. Robustness of the manufacturing processes in all technical, GMP and regulatory aspects
iii. Responsiveness to issues within manufacturing – ensuring expertise is available to quickly recover from issues
iv. Relationships with stakeholders – foundational to ensure performance of cross functional and matrix teams
The Project Lead, Devices leads the Project Teams, including management of ongoing NPI Tools or other Projects, as needed
The role is accountable for assigned Technical Projects by coordinating the necessary resources and setting the priorities to meet the needs of downstream supply requirements and operations.
The Project Lead, Devices will have a understanding of all manufacturing and technical aspects relating to the sites within their portfolio, with a focus on Injection Molded components.
The role will include the close interaction with internal functions as the CDMO / Manufacturing Operations SME on key projects and strategic initiatives.
Must be able to work across multiple time zones.
Periodic travel to CDMO may be required (? 10%)

Responsibilities
• Ensure performance of strategic supply and/or continuous improvement. This is achieved by ensuring reliability to deliver the manufacturing plans, robustness of the processes, responsiveness to issues and building strong relationships with Vendors and internal stakeholders.
• Lead the CMO Project Teams coordinating cross-functional and inter-company activities including assessment of injection mold tooling capability or resourcing needs.
• Lead or support transversal initiative/project to develop the operational excellence culture into External Manufacturing.
• Maintain the appropriate internal and external governance structures to communicate and ensure project success.
• Provide the technical expertise to support CDMO in order to ensure effective processes, optimize capacity utilization and deliver according to state-of-the-art quality standard.
• Perform 1st line troubleshooting and investigation at CDMO for projects in Product.
• Identify continuous improvement and performance improvement opportunities at the CDMO, develop the long-range plans and deliver the projects to achieve improved quality, cycle times and reduced cost of goods.
• Ensure compliance to regulatory standards and industry regulations, implementing best practices, and fostering a strong culture of compliance to always ensure inspection readiness at CDMOs
• Define and manage risk at the CMOs, including capacity availability and potential supply chain disruptions

Competencies
• Subject matter expert in technical / manufacturing aspects related to the portfolio area. Injection molding experience preferred.
• Ability to lead multi-functional teams, influence others, hold teams accountable, results orientated, effective at networking.
• Able to understand and get clear picture on complex, technical and manufacturing performance issues.
• Capable to clearly summarize and present scenarios to support decision-making at senior management level
• Fluent in English (written & spoken)
• Influencing and persuasion skills
• Ability to drive internal cross-functional teams
• Fully self-directed
• Experience in crisis management and associated communication
• Capable of balancing long-term planning / anticipation of risks with responsiveness to immediate issues
• Strong both analytical and conceptual thinking
• Experience in Operational Excellence