Beschreibung
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Consultant for biopharmaceutical API development (m/f)
Referenz: -en
Beginn: asap
Dauer: 36 MM
Ort: in Hesse
Branche: Klinische Forschung
Ihre Aufgaben:
- Technical challenges, regulatory compliance and risk mitigation in upstream/fermentation development with a focus on E. coli host cell systems
- Technical challenges, regulatory compliance and risk mitigation in downstream/purification development
- Technical challenges and risk mitigation in process transfer to CMOs / site transfers
- Establishment and characterization of cell banks
- Implementation of in-process controls
- Process validation and Quality by Design challenge
- Support of development report compilation (design and review)
- Support of master batch record compilation
- Technical and regulatory aspects in manufacturing site (re)construction
- Cleaning validation with a focus on cross contamination/multipurpose facilities
Ihre Qualifikation
- Long-standing industry experience in biopharmaceutical API development as well as in regulatory approvals in the EU and the US, preferrably up to market launch
- Sound expertise in manufacturing techniques for biopharmaceutical APIs
- Expertise in bioanalytical methods would be a benefit
Skills:
- Research Pharma
- Project Management Pharma
Keywords: research researcher laboratory studie pharmaceutical drug Arzneimittel Forschung Studie
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