The New Product Introduction (NPI) team is responsible for the coordination and introduction of new products into QC from Phase 1 to Late Stage NPIs, supporting all testing laboratories.
We are looking for an enthusiastic NPI lead position to join the QC NPI team. In this team, you will be department project lead 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 role that ensures alignment between customers, local and global stakeholders.
• 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.)
• Master/Bachelor degree in Life Sciences, analytical chemistry, bio chemistry, biotech, chemical, lab, engineering
• At least 3 years’ experience in a laboratory/pharmaceutical environment
• Project management experience
• Experience with new product introduction.
• Experience in analytical method transfers and/or raw materials qualifications
• Knowledgeable about a wide range of large molecule analytical methods
• Excellent communication skills (oral and written English). Dutch preferred
• Interpersonal skills and engaged in contact with personnel at all levels within the organization.
• GMP experience in a QC environment
• A quality, compliance and business minded attitude
• Flexible and agile, capable of handling multiple projects and changing priorities
1 July 2021
If you’re interested in the above description, please send your CV.
For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org