Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited.
Post : Biopharmaceutics Scientist
Job Description :
• Assessing the complexity of products in terms of achieving bioequivalence
• Identifying critical material attributes (CMA) of the drug substance and excipients, critical formulation components (CFC) and critical process parameters (CPP) that are expected to affect bioavailability and bioequivalence
• Identifying appropriate in-vitro characterizations tools and methodologies relevant to the in-vivo behavior of the formulations leading to selection of appropriate formulation strategies and/or optimizing formulations to enhance success in bioequivalence studies.
• Analyzing data of bioequivalence studies with an object to identify critical parameters (CMA, CFC, CPP) that led to success or failure and suggest corrective course if required.
• Providing inputs to FRD team regarding critical aspects of the drug release that could be considered while designing bioequivalence studies.
• Development of IVIVC/IVIVR when feasible
• Performing modelling & simulations to predict in-vivo outcome based on in-vitro characteristics
• Preparing biowaiver reports for submission to regulatory agencies
• Addressing regulatory deficiencies related to dissolution and bioequivalence
• Good Communication, Modelling and Simulation using tools like GastroPlus, Phoenix, Simcyp
Candidate Profile : Masters in Pharmaceutics with 3+ years’ experience in Biopharmaceutics, Formulation, Dissolution understanding, IVIVC
Additional Information
Experience : 3+ years
Qualification : M.Pharm
Location : IPDO, Dr. Reddys Labs, Bachupally, Hyderabad, Telangana, India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Biopharmaceutics
End Date : 15th December, 2022
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