AVP/VP-Process R&D-API, Hyderabad

Hetero; Hyderabad; On-site; INR 10,000,000 - 15,000,000; Full time

Job summary

Hetero is seeking a leader to drive API Process R&D, overseeing strategy, development, scale-up, and technology transfer across a diverse portfolio.

You will ensure regulatory compliance, guide DMF/CEP/ANDA submissions, and spearhead green chemistry and digitization initiatives while building a high-performing, cross-functional team.

Qualifications

• 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).
• Strong knowledge of QbD, cGMP, regulatory filings (DMF/CEP/ANDA), and project management.

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.

Skills

API Process Development

Technology Transfer

Regulatory Compliance

People Leadership

Education

Ph.D./M.Sc. in Organic/Pharmaceutical Chemistry

Job description

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).
• Strong knowledge of QbD, cGMP, regulatory filings (DMF/CEP/ANDA), and project management.