Skills :
- Process development responsibility
- Resin screening and selection for new projects
- Process development from small scale shake flask to bioreactor scale ( 1L, 5L, 20L)
- Process scale up till 2KL
- Product / Process studies to support commercial Dossier submissions
- Risk assessment - early stage
- Hold time studies
- Alternative vendors for critical raw Materials assessment
- Process Characterizations
- Viral clearance studies coordination
- Technology Transfers Internal and External
- Scientific and technically sound documentations
Skills Required
Process Development, Risk Assessment, Technology Transfer