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26/02 HR
Executive Search Specialist at HR Cornucopia Pvt Ltd.

Views:71 Applications:10 Rec. Actions:Recruiter Actions:10

Senior Manager - Analytical R&D - Biologics/Biosimilars (8-16 yrs)

Bangalore Job Code: 802527

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.

Education :

- Ph.D. with 8 to 12 Years of experience.

- Master's with 13 to 16 Years of experience

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

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