Assistant Scientist

Job description

Job Description

Requisition ID: 1805696312W

Janssen Infectious Diseases and Vaccines (formerly Crucell) is a biotech company that 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.

Assistant Scientist within Sample Management team and Raw-materials

Department

The 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.

The QCD Labs group focuses on supporting production and laboratory activities with:
·  Inspection, release and change management of incoming production raw materials and laboratory chemicals ( Raw-Materials Team )
·  Sample and Material receipt, handling, storage and forwarding ( Sample Management Team )
·  Cell Culture services where cells are maintained used for assays and production cell line quality is supported (Cell Culture Team)
·  Microbiology group mainly responsible for maintaining controlled state of production clean room and production utilities by environmental and utility monitoring programs (Microbiology Team)
·  Coordination of Release and Stability testing and Outsourcing Coordination (Coordination Team)
·  Lab technicians team is responsible for all internal release and stability testing (Technicians)

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; the Materials and Sample Management Team and Raw-Materials Team on a roughly 80/20 basis to be planned in conjunction with the involved supervisor.

We are looking for a motivated QC technician who enjoys working in a multidisciplinary environment.

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

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

Documentation and Quality (cGMP) 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.

Desired profile

Qualifications

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' experience working in the pharmaceutical industry and working according to cGMP
·  Logistical experience is a pre
·  Strong organizational skills
·  Experience working in a Quality driven environment
·  Good communication in English and Dutch (written and verbally)

Competences

The candidate fit for the job is accurate, pro-active, a team player and capable to build good relations with all stakeholders. He/she is capable of keeping the overview and to optimize processes in a dynamic, strong growing environment. Experience with lab activities in a cGMP environment, where documentation plays a major role, is considered as a must.
Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Vaccines & Prevention BV (8852)
Job Function
Quality Control
Requisition ID
1805696312W