Description

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Biosimilar formulation development leader with 15 years of industrial experience and demonstrated end‑to‑end profile ownership for monoclonal antibody and insulin biosimilars.

Proven expertise in comparability‑driven, QbD‑based formulation strategy, encompassing formulation design and process development, technology transfer, and global regulatory submissions (BLA, MAA, NDS) across globe (US, EU, and Canada).
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Broad technical foundation including drug–device combination products (vial, pre‑filled syringe and cartridge-embedded pen presentations), along with early‑career experience in GLP‑1 analogues, liposomal drug delivery systems, lyophilized injectables, and ready‑to‑use/ready‑to‑dilute formulations.
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Recognized for cross‑functional scientific leadership and mentorship, lifecycle management decisions, and advancing patient‑centric, commercially ready biosimilar products aligned with global regulatory expectations.

Qualifications

Education: B.Sc., M.Sc., B.Pharm., IIP (Indian Institute of Packaging), M. Pharm., B.E./B. Tech (Biomedical, Mechanical, Pharmaceutical, or a related discipline), or equivalent life-sciences/engineering degree

📌 Associate General Manager, Formulation & Development (Ahmedabad)
🏢 Amneal
📍 Ahmedabad