NPI Lead

Job Summary:

Yacht Life Sciences is seeking an experienced NPI Lead to join our Quality Control (QC) team in Leiden. As a key member of our NPI team, you will be responsible for the successful introduction of new products into our commercial lab, ensuring seamless alignment with customer demands and maintaining robustness and feasibility.

Key Responsibilities:

• NPI Project Lead: Serve as the single point of contact for all NPI activities, from Phase 1 to Late Stage NPIs, throughout the CMC stage gates.
• Business Case Development: Create and manage business cases and budget estimations for NPI requests.
• Project Management: Lead NPI transfers, laboratory NPI capacity increase initiatives, and new technologies introduction, including project management, team leadership, and budget control.
• NPI Testing Strategy: Ensure NPI testing plans are aligned with the platform testing strategy.
• Testing Capacity Alignment: Support testing teams in aligning NPI volumes with testing capacity.
• Method Transfer Coordination: Coordinate the analytical method transfer end-to-end.
• Raw Materials Qualification: Oversee the qualification of raw materials.
• Stakeholder Collaboration: Partner with local and global stakeholders to ensure flawless and on-time NPI introduction.
• Laboratory Testing Readiness: Ensure new products introduced have the required robustness and reliability of a commercial lab.
• Process Improvement: Establish and improve standards for content and quality of NPI processes, including change controls, method transfers, documentation, and communication.

Requirements:

• Proven experience in NPI project management and leadership.
• Strong business case development and budget estimation skills.
• Excellent project management and team leadership skills.
• Ability to collaborate with cross-functional teams and stakeholders.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.