NPI Lead

Yacht Life Sciences has a vacancy for a New Product Introduction (NPI) Lead to work at Janssen Biologics in Leiden.

We are looking for an enthusiastic NPI Lead to join the Quality Control (QC) NPI team. In this team, you will be one of the department Project Leads and responsible for introduction of new products into the Leiden lab, both for products manufactured in Leiden and elsewhere. The NPI team ensures flawless NPI introduction meeting customer demands while ensures robustness and feasibility of a commercial lab are maintained. The NPI Project Leads are the multi connector roles that ensures alignment between customers, local and global stakeholders.

Responsibilities:

• SPOC for all NPI activities, from Phase 1 to Late Stage NPIs throughout the CMC stage gates 
• Business case and budget estimations for NPIs requests
• Project lead for NPI transfers, laboratory NPI capacity increase initiatives, and new technologies introduction (e.g. project management, leading the Leiden team, budget control, etc.)
• Ensure NPI testing plan is aligned with the platform testing strategy
• Support the testing teams aligning NPI volumes with testing capacity
• Coordinating the analytical method transfer end-to-end
• Raw materials qualification
• Partner with local and global stakeholders (e.g. DPDS, PQM, Technical Operations, Operations, JSC QC sites, etc.)
• Alignment of NPI global teams and department testing teams needs and requirements to ensure flawless and on-time NPI introduction
• Laboratory testing readiness
• Ensure new products introduced have required robustness and reliability of a commercial lab
• Establish and improve standards for content and quality of NPI processes (change controls, method transfers, documentation, communication, etc.)