NPI Lead

Job Summary:

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

Key Responsibilities:

• Project Lead: Oversee NPI transfers, laboratory capacity increase initiatives, and new technology introductions, ensuring timely and within-budget project delivery.
• NPI Testing Strategy: Collaborate with testing teams to align NPI volumes with testing capacity, ensuring efficient and effective testing processes.
• Method Transfer and Qualification: Coordinate the analytical method transfer end-to-end, ensuring seamless integration with our existing processes.
• Raw Materials Qualification: Ensure the qualification of raw materials to meet our quality standards.
• Stakeholder Alignment: Partner with local and global stakeholders to ensure alignment of NPI global teams and department testing teams' needs and requirements.
• Laboratory Testing Readiness: Ensure our laboratory is ready to support new product introductions, with a focus on robustness and reliability.
• 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, with a focus on quality and customer satisfaction.
• Strong analytical and problem-solving skills, with the ability to collaborate with cross-functional teams.
• Excellent communication and stakeholder management skills, with the ability to build strong relationships with internal and external partners.
• Ability to work in a fast-paced environment, with a focus on meeting deadlines and delivering results.