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 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.)
- Bachelor or Master degree in Life Sciences, analytical chemistry, bio chemistry, or comparable
- > 4 years’ experience in a laboratory/pharmaceutical GMP environment
- Preferably 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)
- Ability to work from home (3 days) and to work on site (2 days)
- Self-starter, initiative-rich, team player
- Interpersonal skills and engaged in contact with personnel at all levels within the organization.
- Shown to have excellent safety and GMP awareness
- 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
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract via Yacht for 1 year (extension is anticipated). Full time preferred, 32 hours can be discussed. Salary between salary between 3000 and 4500 euro gross per 4 week period.
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases.
As a part of JSC QC Leiden situated at the Janssen Biologics Manufacturing 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.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.