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NPI lead QC

Vacaturenummer: A2200088
Janssen Biologics B.V. - Leiden (Nederland)

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

Keywords

  • New product introduction
  • Analytical method transfer
  • GMP
  • QC
  • Project Management


Profile
We are looking for an enthusiastic New Product Introduction lead position to join the 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. The NPI project leads are the multi connector role that ensures alignment between customers, local and global stake holders.
Responsibilities:
  • 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
For this role we are looking for someone with a B.Sc. or M.Sc. in Life Sciences, analytical chemistry, bio chemistry and at least 10 years of experience in a laboratory/pharmaceutical environment.
Other requirements for this position:
  • Experience with new product introduction;
  • Experience in analytical method transfers;
  • Experience with QC;
  • Knowledgeable about a wide range of large molecule analytical methods;
  • Project management experience;
  • Have excellent safety and GMP awareness and experience.

As a person, you are a self-starter, initiative-rich and a real team player. You have excellent communication (English) and interpersonal skills, as you will be in contact with personnel at all levels within the organisation. Additionally, you are flexible and agile, capable of handling multiple projects and changing priorities.


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.



Additional vacancy information
Reference:A2200088
Contract:Temporary contract with CLS Services
Education:HBO/BSc. WO/MSc.
Employment terms:Project for at least 1year, extension possible
50% onsite
Publication date:1-7-2022
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.