Senior Scientist Drug Product Process Development in Nyon area

veröffentlicht
Kontakt
Coralyne Saint-Cirel, Genf Professionals Health Care & Life Sciences
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Nyon area
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
14765
Kontakt
Coralyne Saint-Cirel, Genf Professionals Health Care & Life Sciences
Telefon
058 201 54 40

Stellenbeschreibung

CONTRACT DURATION: 12 months MAIN TASKS:
  • Oversee outsourced (CDO, CMO) drug product activities around the technical development including, drug product process development and generation of drug product, clinical trial supply, process characterization and validation and submission of CMC documents
  • Strategically define the technical corridor for analytical similarity to be achieved when developing products
  • Contribute to the selection of the primary container
  • Review and approve external protocols / reports and other documents
  • Assume a technical leading role in Drug Product tech transfer activities for handover and scale up of projects to internal and external GMP manufacturing sites
  • Define technical development that follows the principles of Quality by Design (QbD)
  • Provide scientific and technical operational guidance for the drug product process development activities to the Development Teams and the Leadership Team
  • Prepare and review (when appropriate) the CMC section of the regulatory dossier
  • Represent Drug Product Process Development at cross functional meetings
PROFILE:
  • Masters in Science or Engineering, or BSc with added experience
  • Fluency in English essential, French and/or German would be an asset
  • Minimum 7 years’ experience in Pharma/Biotech Industry with demonstrated track record in Drug Product processing for biologics
  • Strong technical and scientific expertise across the Drug Product development spectrum including process development, scale up, tech transfer, process characterization and large scale manufacturing