Associate Scientist QC NPI
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for an Associate Scientist QC NPI.
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.
We are looking for an enthusiastic NPI lead position 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. 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;
- 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;
- 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.
Who we're looking for
For this role, we are looking for a BSc or MSc candidate with a background in Biotechnology, Biochemistry or Engineering and at least 4 years experience in the pharmaceutical industry.
Experience with Project Management and GMP experience in a QC environment are a must have. Besides this, you have experience with new product introduction and in analytical method transfers and/or raw materials qualifications. You have knowledge of a wide range of large molecule analytical methods.
We are looking for a candidate with excellent communication skills in English and preferably also in Dutch. As a person you can describe yourself as a self-starter who takes initiative and a good team player. You must be able to work on multiple simultaneous tasks with limited supervision and set priorities yourself.
Are you the experienced candidate we are looking for?
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
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Contract for at least one year.|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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