Sun Pharma -R&D Baroda
Sr Officer / Executive – Biopharmaceutics
Qualification : M.Pharm in Biopharmaceutics OR Pharmacology
Experience : 1-4 years.
1. Assessing the complexity of products in terms of achieving the bioequivalence.
2. Identifying critical material attributes (CMA) of DS and excipients, Critical formulation components (CFC) and critical process parameters (CPP) that are expected to affect the bioavailability and bioequivalence of differentiated formulations.
3. Identifying appropriate in vitro characterization tools and methodologies relevant to the in vivo behavior of the formulations leading to selection of appropriate formulation strategies and /or optimizing formulation to enhance success in bioequivalence.
4. Providing input on critical aspects of the drug release that could be considered while designing bioequivalence studies for differentiated formulations.
5. Development of IVIVC/IVIVR when feasible for differentiated formulations.
6. Performing modelling and simulations to predict in vivo outcome for differentiated formulations using different software’s such as PHOENIX, WINOLIN, R AND S PLUS, NONMEM, DDD PLUS, GASTROPLUS.
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