Vice President

Job Description : Vice President – API R&D Location: Hyderabad Industry: API Pharmaceuticals Experience: 20+ years Education: M.Sc . in Organic Chemistry with Ph.D. Offered CTC: Up to ?1.00 Cr per annum Role Summary: We are seeking a dynamic and experienced Vice President – API R&D to lead the API Research & Development function for a reputed pharmaceutical company based in Hyderabad. The ideal candidate will oversee the development of new chemical entities (NCEs), generic APIs, and process optimization initiatives, ensuring high-quality, cost-effective, and timely delivery from lab to commercial scale. Key Responsibilities: Leadership & Strategy Define and drive the strategic roadmap for API R&D, encompassing Process R&D, Technology Transfer, and Analytical Development. Build, mentor, and lead a high-performance scientific team. Align R&D efforts with overall business goals and global regulatory expectations. Technical & Scientific Expertise Lead the development of robust, scalable, and regulatory-compliant synthetic routes for APIs. Review and approve protocols, reports, and technology transfer documents. Collaborate closely with cross-functional teams including IP, Regulatory Affairs, QA/QC, and Manufacturing. Innovation & Process Optimization Foster a culture of continuous innovation in API synthesis and process engineering. Implement Quality by Design (QbD), Design of Experiments (DoE), and Process Analytical Technology (PAT) for development excellence. Drive cost optimization through process innovation and reengineering. Regulatory & Compliance Ensure compliance with global regulatory standards (USFDA, EU-GMP, WHO, etc.). Support the preparation and submission of Drug Master Files (DMFs) and other regulatory documentation. Coordinate with regulatory authorities and ensure audit readiness. Project & Stakeholder Management Manage a diverse portfolio of API projects across development phases. Collaborate with Business Development, Supply Chain, and Manufacturing to ensure timely execution. Engage with global clients and CDMO partners to deliver project excellence. Desired Candidate Profile: Proven track record in leading API R&D for regulated markets (US/EU/ROW). Strong scientific grounding in synthetic organic chemistry and scale-up. Demonstrated leadership in managing large scientific teams. Excellent communication and client interaction skills. Prior experience with CDMO projects is a plus.

---

Back