Executive Search Specialist at HR Cornucopia Pvt Ltd.
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Senior Manager - Analytical R&D - Biologics/Biosimilars (8-16 yrs)
Senior Manager - Analytical R&D - Biologics/Biosimilars
Technical Skill :
- Subject Matter Expert Knowledge in Mass spectrometry, Glycan Chromatography, Spectroscopy based protein characterization methods.
- Experience in Analytical method development qualification, characterization of Biosimilar / Biologics.
- Experience in managing large team (10+)
- Solving complex analytical problems.
- Experience in preparing regulatory submissions to the FDA, EMA and other regulatory authorities.
Key Responsibility :
- Physicochemical lead for the characterization of Biologics
- Managing a team of 10+ members of method development qualification and sample analysis for Biosimilar, Direct coordinate, organize and prioritize group deliverables.
- Review of the technical report documents.
- Preparing regulatory dossier sections for global submissions.
- Cross Function interaction with internal and external stakeholders.
- Ph.D. with 8 to 12 Years of experience.
- Master's with 13 to 16 Years of experience
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