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NPI Project Lead QC

Vacaturenummer: A2100141
Janssen Biologics B.V. - Leiden (Nederland)

For our client, Janssen Biologics B.V., we are looking for a NPI Project Lead QC.

Keywords

  • GMP
  • Project management
  • NPI
  • Analytical Methods


Profile
We are looking for an enthusiastic NPI project lead to join QC Leiden 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. You are the multi connector that ensures alignment between customers, local and global stake holders.
Responsibilities and Accountabilities:
  • 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;
  • Co-ordinating the analytical method transfer end-to-end;
  • Raw materials qualification;
  • Partner with local and global stake holders (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.).


Who we're looking for
You have a Master or Bachelor degree in Life Sciences, analytical chemistry, bio chemistry, or comparable. At least 4 years of experience in a laboratory/pharmaceutical environment with GMP experience in a QC environment and 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);
  • Self-starter, initiative-rich, team player;
  • Shown to have excellent safety and GMP awareness and experience.


Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Department
As a part of JSC QC Leiden situated at the Janssen Biologics Manufacturing site, the New Product Introduction (NPI) team is responsible for the co-ordination and introduction of new products into QC Leiden, from Phase 1 to Late Stage NPIs, supporting all testing laboratories in QC Leiden.

Additional vacancy information
Reference:A2100141
Contract:Temporary contract with CLS Services
Education:HBO/BSc. WO/MSc.
Employment terms:Salary: 3000 - 5000 EURO
Days of leave: 25 + 11
See here our other employment terms for this vacancy
Publication date:29-6-2021
Location:View location with Google Maps
Contactperson:René Kemps
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.