Job Description

Job Summary
Responsible for end-to-end Formulation development including development, execution, filing and approval.
Assess process feasibility to enable effective product and process knowledge transfer.
Support selection of suitable manufacturing equipment and establish batch sizes based on plant capabilities.
Prepare and review master manufacturing records, batch documents, technology transfer packages, development reports, and regulatory filing documentation.
Execute and support scale-up, exhibit, validation, submission, and commercial batches.
Ensure availability of equipment, materials, tooling, and supporting resources at the receiving manufacturing site.
Provide in office and remote technical support during technology transfer, validation, and commercial manufacturing.
Collaborate with Manufacturing, Quality Assurance, Analytical Development, Regulatory Affairs, Supply Chain, and external partners to ensure successful project execution.
Prepare investigation reports,



technical assessments, and scientific justifications based on laboratory and manufacturing observations.
Support manufacturing and Quality teams in implementing process improvements and corrective actions.

Regulatory & Compliance Responsibilities
Support preparation, review, and compilation of product license applications, regulatory dossiers, and submission packages for global markets.
Address regulatory queries, deficiency letters, and health authority questions by providing accurate scientific data and technical justifications.
Ensure the quality, completeness, and compliance of regulatory responses to facilitate timely approvals.
Prepare and review risk assessments related to:
Elemental Impurities
Nitrosamine Risk Assessment and Mitigation
Residual Solvents
Product quality, process, and regulatory risks

📌 Formulation Scientist Hyderabad (India)
🏢 Dr. Reddy's Laboratories
📍 India