For my leading Biotech client in Leiden I am looking for a NPI Coordinator responsible for delivery and tech transer of the NPI process to the manufacturing site, resupplies and phase changes of API and DP clinical materials per CMC timelines. One year contract with high change of extension.
- 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.
· In collaboration with Operations and Quality, review and approve required GMP documentation for manufacturing production.
· Partner with site operations and CMC sub-teams, to ensure on-time, end-to-end supply chain delivery of GMP API clinical supplies
· Report to Operations Manager, representing and leading operations on cross functional project teams
· Be familiar with daily activities in Manufacturing, continuous improvement, Lead investigations and supporting training of other Manufacturing colleagues.
· 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.
· Experience in clinical or commercial manufacturing is required.
· Knowledge of cGMP’s and Agency requirements for biopharmaceutical manufacturing is required.
· 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 Supply Chain: planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of biopharmaceuticals is required.
Duration: 1 year contract, likely to extend.
Start: ASAP (flexible)
Set-up: Min. 3 days on-site
Hours p/w: Fulltime (40 or 36 hours)
Get in touch ASAP by sending your CV to firstname.lastname@example.org or call me on +31202044502! You can also refer a friend and both earn a bonus on placement.