SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
The companyOur client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands. Our client is a professional Pharmaceutical organisation, based in Netherlands. In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves.
Role descriptionThe 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 our 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)
ResponsibilitiesBased on formation plan and the needs within the QCD Labs organization, we are looking for a motivated technician who enjoys working in a multidisciplinary environment.
Main tasks of an Assistant Scientist are:
- Taking part on all activities related to Release and Stability testing of cGMP TOX and clinical batches of Biopharmaceutical products: Vaccines.
- Performing assays like: GPT, Control Cell, VPQPCR, QPA, LC-techniques, DCS, Sub-visible Particles, WB, pH, Osmolality, HC DNA, ELISA’s and ID PCR
- Culturing of cells (e.g. A549, HEK293), in order to keep cells maintained for assays.
- Ensuring that a high level of Quality is maintained in the department.
- Accurate completion of documentation such as assay run sheets (ARS), laboratory notebooks and logbooks.
- Actively participate in setting up documentation to ensure compliance.
- Participate in continuous improvement projects that progresses the department in quality, EHS and efficiency gain.
- Becoming assay responsible person for an assay performed within the team, including updating of test instructions for GMP assays.
Requirements- MLO or HLO, affinity with medical products and experience with quality and laboratory systems such as cGMP, LIMS are strong advantages.
- Candidate is accurate, pro-active, a team player and careful.
- Minimum of 3 years’ experience working in the pharmaceutical industry.
- Experience with lab activities in a GMP environment or similar is considered as a pre.
- Experience working in a Quality driven environment.