Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.
The NPI Coordinator is responsible for delivery of the NPI process to the manufacturing site for NME’s, resupplies and phase changes of API and DP clinical materials per CMC timelines.
- Setup and lead project kickoff meetings, weekly workcells, and other tech transfer meetings, as necessary, to coordinate efforts among BTDS for delivery of GMP clinical materials.
- Act as the single point of contact (SPOC) between CMC and CSC teams / members and the Site Operations team, regarding tech transfer and GMP DS clinical supplies updates.
- Monitoring and reporting of process performance for supply chain and NPI tech transfers
- Partner with site operations BCPO and BTDS colleagues to ensure on-time, end-to-end supply chain delivery of GMP API clinical supplies
- Participate in CMC sub-teams and cross-functional meetings, as needed, to provide sourcing, operational and supply chain expertise.
- A Master Degree in the Life Sciences or Engineering is required. A minimum of a MSc degree with 5+ years of experience is preferred, or a PhD degree with 3 years of experience.
- Ability to effectively apply project management tools to lead projects and programs is required. Knowledge of FPx is preferred.
- Working knowledge of the following facility and site operations areas are required: facility design, HVAC, process utilities, room and equipment cleaning, and equipment qualification.
- Experience with the following API manufacturing processes is required: cell culture and harvest, viral inactivation, filtration, purification
- Understanding of planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of biopharmaceuticals is required.
For more information please contact Ece Karakurt at firstname.lastname@example.org or +31 (0) 20 658 98 01.