New product Introduction (NPI) Lead QC
For one of the leading pharmaceutical companies, we are looking for an enthusiastic NPI lead to join QC Leiden NPI team. As a part of QC Leiden site, the New Product Introduction (NPI) team is responsible for the coordination and introduction of new products into QC Leiden, from Phase 1 to Late Stage NPIs, supporting all testing laboratories in QC Leiden.
You will be department project lead and responsible for NPI. The NPI team ensures flawless NPI introduction meeting customer demands while ensures robustness and feasibility of a commercial lab are maintained.
- 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, or comparable
- At least 10 years’ experience in a laboratory/pharmaceutical environment
- Project management experience and Quality Control
- 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)
- Shown to have excellent safety and GMP awareness and experience
- A quality, compliance and business minded attitude
- Flexible and agile, capable of handling multiple projects and changing priorities
- Strategic thinking, balance short and long term priorities
Starting date: ASAP
50% on site
12 months, extension is possible (depending on performance & business need)
Interested? Send me your CV, firstname.lastname@example.org
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