Beschreibung
Principal Scientist Drug Products (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Main tasks:
- Support the analytical project leads in phys-chem QC in execution of customer programs for parenteral biologics as requested: pre-clinical to clinical stages in regulated environment, also applying cGMP rules
- Review and approve as requested of analytical results of mainly stability studies applying the following methods and technologies
- HPLC and CE purity methods, content by UV, compendial methods: color, clarity and opalescence, pH, osmolality, extractable volume, visual inspection, subvisible particles
- Support in data review of validation runs (methods see above) and compiling data presentation in validation reports upon request
- Follow the established test methods and SOPs of the phys-chem QC; especially the cGMP regulations where required; adhere to good documentation practices
- Ensure proper maintenance of equipment, safety and health protection following lab and safety instructions and all cGMP regulations
Main qualifications
- Degree (MSc, Diploma) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Experience in QC and under cGMP regulations in the pharmaceutical or chemical industry dealing with analytics of biomolecules e.g. mAbs
- Very good knowledge in relevant analytical techniques
- Good working experience in Waters cds Empower
- Good reporting, interpretation and documentation of scientific results
- Experience with parenteral dosage forms, protein
- Very Good knowledge of written and spoken English
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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