Purpose: Product Characterisation using Analytical Methods
Key Responsibilities:
- Development of Analytical Methods for Production Characterisation of proteins and polysacharides
- Experience in Development of Methods using SEC-MALLS, Ion Chromatography, GPC and other Chromatographic methods
- Experience in Method Validation and Transfer
- Preparation of Standard Operating Procedures, Reports, Stability Protocol, and other reports.
- Preparation of Documents for Dossier Submission
Operating Network:
Internal Head - ARD, Other Analytical Experts in AR&D, CR&D, and FR&D, IPM, DQA, SCM, HR.
External: Vendors
Technical Requirements: Understanding of using various Scientific Literature and guidelines from ICH / EMEA / FDA /PMDA, Good Technical writing skill, Good training skills, Strong analytical thinking and data mining skills
Educational & Experience: MSc with 7 Years or PhD with 2-3 years- experience
Key Personal Attributes:
- Good Communication skills
- Networking skills
- Time management and work prioritization ability
- Confident
- Self-starter (should be able to work independently with minimal supervision).
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