Hetero
Website:
hetero.com
Job details:
AVP/VP – API Process R&D
Function
API – Research & Development
Location
Hyderabad, Telangana, India
Reports To
Head - R&D
Experience
18–25 years, including 8–10 years in a leadership role
Role Summary
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.
- 18–25 years of API Process R&D experience, including 8–10 years in a leadership role.
- Proven expertise in API process development, technology transfer, and commercialization for regulated markets (US, Europe, Japan).
- Strong knowledge of QbD, cGMP, regulatory filings (DMF/CEP/ANDA), and project management.
Hetero is an equal opportunity employer.
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