Team Lead Generic API Development ( Phd Organic Chemistry)

CLIENT: Leading developer and manufacturer high-quality Active Pharmaceutical Ingredients (APIs) for global markets. It has developed and supported complex molecules to over 500 customers, supported by US FDA and EDQM compliant facilities.

Position Summary

We are seeking an accomplished Team Lead for API Generics R&D to drive end-to-end development of cost-effective, patent-non-infringing synthetic processes for small-molecule APIs. The role demands deep expertise in organic chemistry, strong experience in patent analysis and regulatory DMF filings, and proven leadership of high-performing scientific teams. The incumbent will lead multiple projects from route scouting through technology transfer, ensuring quality, timelines, and compliance with global regulatory standards.

KEY DELIVERABLES:

• Lead, mentor, and develop a team of 810+ scientists for design and development of non-infringing synthetic routes for generic APIs.
• Oversee route scouting, optimization, impurity profiling, and scale-up readiness.
• Drive innovation in process chemistry to achieve cost, yield, and sustainability targets.
• Troubleshoot complex chemistry challenges during development and scale-up.
• Ensure readiness for technology transfer to pilot plant and manufacturing.
• Conduct and guide patent landscape analysis and infringement assessment.
• Perform comprehensive literature searches (patents, journals, regulatory sources).
• Lead preparation and review of Drug Master Files (DMFs) and technical packages.
• Ensure compliance with USFDA, EMA, PMDA, and other global regulatory requirements.
• Maintain high standards of documentation, data integrity, and audit readiness.

INCUMBENT PROFILE:

• PhD /Postdoctoral research in Organic Chemistry from a reputed international university.
• Extensive experience in API Generics R&D (process development).
• Demonstrated expertise in patent evaluation and infringement studies.
• Proven track record of filing DMFs (US/Europe preferred).
• Strong publication or patent record is desirable.

Queries:

Anoop Sinha- CEO,PROFILE HR CONSULTANTS PVT LTD

Cell- 9773520069