• LEIDEN
  • 40 uur
  • MBO, HAVO, VWO
  • € 2550 - € 2800  per maand
solliciteren

Assistant Scientist Raw-materials and Sample Management team


  • 02 februari 2018
  • LEIDEN
  • 40 uur
  • MBO, HAVO, VWO
  • € 2550 - € 2800  per maand

functieomschrijving

  • 02 februari 2018
  • vacaturenummer: 34910

Currently, we are looking for an Assistant Scientist within the Raw-materials and Sample Management team of Janssen Vaccines & Prevention (formerly Crucell) who enjoys working in a multidisciplinary environment.

Janssen Vaccines & Prevention is a biotech company which is part of the Pharmaceutical Companies of Johnson & Johnson and focuses on the development, production and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.
Within Janssen talented, entrepreneurial people are working in a dynamic culture in which innovation and a ‘can do’ state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.

Department
The Quality Control Development (QCD) labs group is part of the Analytical Development Department of the Pharmaceutical and Analytical Development sector. Overall, the QCD Labs unit consist of 6 sub-teams (Raw-Materials, Sample Management, Cell Culture, Microbiology, Coordination and Technicians) and is responsible for release and stability testing as well as the corresponding reporting of Janssen’s virus and antibody products for use in clinical trials and the analytical support of the pilot plant activities.

Job description
Based on formation plan and the needs within the QCD Labs organization, this function is to operate within two of the QCD labs groups; Raw-Materials Team and the Materials and Sample Management Team on a roughly 80/20 basis to be planned in conjunction with the involved supervisor.

Within the Raw-Materials Team incoming purchased raw materials used within cGMP activities are inspected and tested to support the release of the material for use. Main tasks for the team are:
- Perform physical and documentation inspections and labeling on incoming raw materials
- Taking samples of raw materials and make sure these are distributed to various (external) testing laboratories.
- Perform various tests on incoming raw materials as identification, pH, conductivity and osmolality.
- Receipt and record inspection and test results
- Review of work performed by colleagues
- Supplier changes
- Setting up specification documentation for raw materials
- Having close contact with warehouse and users

Within the Materials and Sample Management Team Materials and Samples used for Release and Stability Testing are received, stored and forwarded to external parties according to GMP. Main tasks of the team are:
- Sample receipt, storage and forwarding according to cGMP
- Preparation of shipping documentation
- Maintain up to date lab planning
- Maintain up to date inventory of materials and samples
- Process and review incoming Certificates in the appropriate systems (e.g. LIMS)
- Support Coordination Team with LIMS configuration

Documentation and Quality (GMP) and efficiency improvements are important factors within Analytical Development. It may be an excellent opportunity for Technicians who want to pursue their career in a job more outside the labs.

Minimum Qualifications
- MLO or HLO, affinity with medical products and experience with quality and laboratory systems such as cGMP, SAP and LIMS are strong advantages.
- Precise and Careful
- Minimum of 3 years of experience working in the pharmaceutical industry
- Strong organizational skills
- Experience working in a Quality driven environment
- Good communication in English and Dutch (written and verbally)

Competences
- Accurate
- Pro-active
- Reliable
- Independent but also a team player
- Capable to build good relations with all stakeholders
- Capable of keeping the overview and to optimize processes in a dynamic, strong growing environment

Salary indication: between €2.550,- - €2.800,- gross per month (based on fulltime), depending on experience and education.

Uiteraard staat deze vacature open voor zowel mannen als vrouwen.

contact

Vinkestijn-de Jong, Marit
marit.vinkestijn@nl.randstad.com
0647947697

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