Bi osimilar formulation development leader with 15 years of industrial experience and demonstrated end‑to‑end profile ownership for monoclonal antibody and insulin biosimilars. Pr oven 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).
Br oad 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.
Re cognized for cross‑functional scientific leadership and mentorship, lifecycle management decisions, and advancing patient‑centric, commercially ready biosimilar products aligned with global regulatory expectations. E d ucation: B.
📌 Associate General Manager, Formulation & Development (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad
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