Lead the API Process R&D; groups by driving process innovation, development, scale-up, technology transfer, and commercialization of API products. Ensure robust, scalable, cost-effective, and regulatory-compliant manufacturing processes while building high-performing teams and supporting global business growth.

KEY RESPONSIBILITIES

- Define and execute the API Process R&D; strategy in alignment with overall business goals.
- Lead process development, optimization, and commercialization of API molecules across the portfolio.
- Oversee scale-up, technology transfer, and commercial manufacturing support from lab to plant.
- Ensure compliance with cGMP, ICH, USFDA, EMA, and other global regulatory requirements.
- Review technical documents supporting DMFs, CEPs, ANDAs, and other regulatory submissions.
- Drive innovation, green chemistry, digitalization, and cost-optimization initiatives across R&D.;




- Manage the R&D; project portfolio, timelines, and budgets through cross-functional collaboration.
- Lead, mentor, and develop Group Leaders, Scientists, and R&D; Managers to build a high-performing team.

QUALIFICATIONS & EXPERIENCE

- Ph.D. / M.Sc. in Organic Chemistry, Pharmaceutical Chemistry, or Chemical Sciences.
- 1825 years of API Process R&D; experience, including 810 years in a leadership role.
- Proven expertise in API process development, technology transfer, and commercialization for regulated markets (US, Europe, Japan).
- Solid knowledge of QbD, cGMP, regulatory filings (DMF/CEP/ANDA), and project management.

Interested Candidates share your resume to vivek,[email protected]

📌 AVP/VP-Process R&D-API, Hyderabad
🏢 Hetero
📍 Hyderabad