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- Accountable for all DSP related activities, that includes development, tech transfer, GMP support, scale-up scale down studies, PC, PV and life cycle management activities
- Should have complete understanding of CMC-regulatory requirements for DS sections in the domain. Accountable to support all the pre-requisites for regulatory filings.
- Draft and review all domain specific documents (protocol reports, etc.)
- Draft and review CTD sections for BLA submission
- Review GMP documents
- Identify innovative & novel technologies in co-ordination with the suppliers to build future capabilities
Lead - Downstream Processing Biosimilar - Bengaluru, India - Cipla
