ASSOCIATE SCIENTIFIC MANAGER I

Department Details

Role Summary

Formulation development OSD.
To look after Market extension to emerging markets.

Key Responsibilities

1.Formulation Development: Develop and optimize robust oral solid dosage forms using QbD/DoE principles, ensuring bio-performance, stability, manufacturability, and cost effectiveness for regulated and emerging markets.
2. Scale-up & Tech Transfer: Support scale-up, exhibit/validation batches, identify CMAs/CPPs, establish control strategies, and provide manufacturing support for smooth commercial transition.
3. Regulatory Filings: Prepare and support CTD/ACTD Module 3 dossiers for US, EU, and emerging markets, including scientific justifications for formulation, process, dissolution, and specifications.
4. Stability & Dissolution: Design and evaluate ICH stability studies and develop discriminatory dissolution methods with biorelevant interpretation to sup...