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API R&D Tech Lead (CIP)
Dr. Reddy's Laboratories
Hyderabad, IND
Full-time
Senior · 10+ years experience
Onsite
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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 safe, 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.
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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 safe, 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, efficient, and green synthetic routes.
- You will be responsible for planning and executing experiments using QbD principles to develop robust, safe, and scalable processes.
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