About Company:
Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Backed by 25 years of expertise in the pharmaceutical industry, Hetero’ s strategic business areas spread across APIs, generics, biosimilars, custom pharmaceutical services and branded generics. The company is globally recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products. Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, approved by stringent global regulatory authorities. Our portfolio includes 300 plus products encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology, Urology, Diabetes, Ophthalmology, Hepatology and Immunology etc. Hetero has a strong global presence in over 145+ countries and focusses on making affordable medicines accessible to patients worldwide.
Website
http://www.hetero.com
Vacancy Details:
Position: Group Leader(OSD) Formulation & Development
Qualification: M. Pharm / Ph.D. (Pharmaceutics).
Experience: 13 years+
Work Location: Hetero Labs, Unit II, Gandhinagar, Hyderabad
Key Responsibilities:
1.Lead OSD formulation development for US & Europe markets.
2. Oversee scale-up, technology transfer, and validation.
3.Ensure regulatory compliance (USFDA, EMA, ICH) and support ANDA/NDA filings.
4. Implement QbD, DoE, and optimize formulations for cost & quality.
5.Guide & mentor the formulation team, collaborate with cross-functional teams
Required Skills:
1.Expertise in immediate-release, modified-release, and complex formulations.
2. Strong knowledge of GMP, regulatory guidelines, and bioequivalence studies.
3. Experience in dossier preparation, troubleshooting, and manufacturing support.
EMAIL:
vijaybabu.r@hetero.com