AGM - Formulation and Development for ROW & Domestic market
3 weeks ago
Qualification – M. Pharma/Ph. D. (Tech)
Experience – 15 to 20 years experience in Product Development for ROW / Domestic Market for solid oral dosage forms. Experience of managing team of 6 - 8 Formulators.
Location: Kandivali, Mumbai.
Experience of ROW market & Domestic market is mandatory.
Job Description –
Designing the Formulation Strategies based on the literature search, Patent Evaluation of Oral Solid dosage forms for ROW / Domestic Market.
New Product Development for oral solids - Domestic & ROW Markets.
Support manufacturing of scale up and validation and commercial batches
Worked on the different projects like immediate release, Extended Release products.
Design of in-vitro tools / Discriminatory media development to take decision for Pilot and Pivotal BE studies.
Evaluation and interpretation of Pharmacokinetic / bioequivalence data and future Strategy decision.
Evaluation and interpretation of Analytical and stability data and work closely with analytical managers to ensure analysis plan is finalized and communicated with timelines on day-to-day basis.
Preparation of various regulatory documents which are auditable like MMD, PDR, MFC, MPC, BMR, BPR etc.
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