Associate Scientist QC - Raw Materials
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for an Associate Scientist QC - Raw Materials.
As a part of the QC laboratories, the Chemical, Physical & Raw Materials (CPRm) team is responsible for the execution of test methods using various analytical techniques. The scope of products varies from biologicals and vaccines, derived from early clinical batches up to commercial batches. The testing of the more than 150 raw materials is outsourced to a network of external test laboratories.
You will be working in a team of 10 colleagues, that is exclusively concerned with the QC aspects of clinical and commercial raw materials.
Management of deviations in respect to raw materials testing:
- Acting as lead investigator for local/global Non-Conformances which encompasses conducting the investigation, providing impact assessments, and identifying and defining appropriate corrective and preventive actions;
- Supporting and advising other investigators from external and internal QC departments.
Timely release of raw materials:
- Review of the release packages coming from internal and external contract laboratories;
- Resolve deviations identified in the release package, by performing the corrections yourself or coordinating implementation of the corrections by other teams e.g., Global Planning, Warehouse and external contract laboratories;
- Release of the raw materials in SAP, our enterprise resource planning system.
Providing scientific and technical analytical support to the testing laboratories:
- Serve as an expert on physical and chemical technologies used for raw materials testing and will be requested to represent the team during internal/external meetings. Act as a Subject Matter Expert (SME) during audits and inspections and write observation responses;
- Lead or participate in exciting projects or studies to maintain quality of the testing of the raw materials;
- Lead and drive continuous improvement processes to contribute to a lean culture in the area of testing and to improve our cost competitiveness.
Introducing of new raw materials and new analytical technics;
- Transfer of new analytical techniques to the (external) testing laboratories, in close corporation with our USA-based development team;
- Design of an optimal test strategy for new materials to reduce the time between the arrival of a material and the release for usage.
Who we're looking for
You will bring an university degree (bachelor, master or PhD) in Analytical Chemistry, Pharmacy or equivalent and 3-5 years of experience in a Quality Control environment with demonstrable knowledge of pharmaceutical raw materials and associated regulations. You have good knowledge of GMP/GLP guidelines. Additionally you have proven capabilities in managing smaller and/or larger projects. As a person you are result-oriented, a team player and a self-starter.
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.
The Chemical, Physical & Raw Materials (CPRm) department is part of the Quality Control (QC) department of Janssen Biologics B.V. The CPRm department consists of 40 highly skilled employees of a total of 280 employees within QC.
These are the 4 main work areas for this young, highly motivated team:
· Coordination of all raw material sample handling and testing for already qualified materials as well as new materials.
· Handling of quality events related to testing of raw materials at the contract laboratories
· Review of test results and release of raw materials for commercial use for our production sites in Leiden and Cork (Ireland)
· Introduction of new Raw materials and the qualifications of new sources of existing materials to meet the business needs.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Education||:||HBO/BSc. WO/MSc. PhD.|
|Employment terms||:||Contract for at least one year, extension possible.|
Salary: 40000 - 54000
Days of leave: 36
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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