Are you a scientist with experience working on antibodies / vaccines in a pharmaceutical setting under GMP? We have a new challenge for you where you will be working on the introduction of a new product (NPI).
As a Scientist you will work at a large pharmaceutical company within the clinical production department. You will be involved in major process improvements in collaboration with different departments. There are several new products being introduced at the site, you will be dedicated to one project. This work involves process development at a small scale, being part of a team for large scale engineering batches, PPQ batches, and regulatory submission writing. In addition you will apply the latest Technological Innovations into the daily work. One of the major innovations currently explored is data management and statistical analysis applied to bioprocessing.
- Responsible for the technology transfer of the process from vial thaw until final fill of the drug substance.
- Writing Batch records for clinical production
- In charge of coordination of all the logistics with respect to materials and equipment for the clinical production
- Process development using PPQ batches
- Responsible for managing the level materials present on site
- Managing different people on site to ensure the proper steps are followed.
- PhD with 3 years of working experience in Biotechnology, Bioprocess Engineering, Biochemistry, Biochemical engineering
- Masters degree with 5 years of working experience in a similar environment as stated above.
- Preferably knowledge on bioreactor process technology and downstream purification of large molecules (protein/Antibodies/duo bodies) for R&D purposes (GLP toxicology & GMP clinical)
- Experience with data management techniques, statistical software packages, Multivariate analysis and PAT
- Experience with process validation, process improvements, and manufacturing support.
- Familiar with process improvements (Six Sigma)
- Contract: 1 year via Oxford, realistic long- term perspective
- Location: 80% remote work, 20% onsite.
- Salary: €3600- €5000 gross monthly based on a full-time position
- Holidays: 25
- Working hours: full-time, 32 hours discussable
- Region: Leiden
- Vacancy number: 17250
Oxford Global Resources is the largest recruitment agency within the fields of Science, Engineering and IT. All our recruiters have a relevant background within these fields and can help you find the perfect job through our extensive network.
As a specialist company we have a wide range of laboratory vacancies in Quality Control (QC) and Research & Development (R&D) within various sectors, including Pharmaceuticals, Biotechnology, Contract Manufacturing, Contract Research, Food Industry, Chemicals, Environment and Plants.
Oxford is always looking for talent with expertise in Biotechnology, Immunology, Biochemistry, Virology, Microbiology, Molecular Biology, Life Science, Analytical Chemistry, Physical Chemistry, Polymer Chemistry, Petrochemistry and Diagnostics. We are keen to meet candidates who have experience in one or more of the following techniques: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, virus culture, cell culture, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, cloning, sequencing, protein purification, purification, HPLC, UPLC, chromatography, physical chemistry, viscosity, melting point, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titrations, Karl Fisher, formulation, sterility, determinations, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.
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