Job Description

Job Summary

This role is for a process chemistry leader responsible for defining non-infringing API routes and driving end-to-end process development from feasibility to commercialization. The role focuses on route selection, cost strategy, and alignment with IP, regulatory, and sourcing requirements. You will lead process optimization using QbD principles to develop protected, scalable, and cost-effective manufacturing processes. The position involves close collaboration with cross-functional teams to ensure seamless tech transfer and plant execution. You will monitor plant performance, troubleshoot scale-up issues, and ensure compliance with quality and regulatory standards. Additionally, the role includes supporting DMF filings, addressing deficiencies, and driving innovation. Mentoring teams and managing project execution across multiple products are key expectations.

Roles & Responsibilities

• You will be responsible for defining non-infringing route selection strategies through literature evaluation, risk assessment, and alignment with IP, RA, SCM, and portfolio teams.





• You will be responsible for driving feasibility, optimization, and execution of cost-effective, effective, and green synthetic routes.

• You will be responsible for planning and executing experiments using QbD principles to develop robust, protected, and scalable processes.

• You will be responsible for leading cross-functional coordination, phase gate reviews, and ensuring timely project progression.

• You will be responsible for supporting tech transfer, monitoring plant performance, and troubleshooting scale-up and commercial batch issues.

• You will be responsible for ensuring regulatory compliance, including DMF documentation, impurity control, and response to deficiencies.

• You will be responsible for defining specifications, control strategies, and ensuring toxicological and safety assessments (e.g., genotoxicity, nitrosamines).

• You will be responsible for mentoring teams, driving innovation, and supporting intellectual property and technology development.

📌 Api R&d Tech Lead Cip Hyderabad
🏢 Dr. Reddy's Laboratories
📍 Hyderabad