Biopharmaceutics Scientist

1 week ago

Bachupally Hyderabad Telangana, India Dr. Reddy's Laboratories, Inc. Full time

**Key Responsibilities**:

- 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

**Education **& **Experience**:

- Masters in Pharmaceutics with 3 + years’ experience in Biopharmaceutics, Formulation, Dissolution understanding, IVIVC

Skills Required: Gastroplus, IVIVC, Biopharmaceutics

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