19/07 Reshma
Sr consultant at CIELHR

Views:148 Applications:1 Rec. Actions:Recruiter Actions:1

Senior Scientist - Biopharmaceutics (10-14 yrs)

Hyderabad Job Code: 7027

- 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 behaviour 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 input to clinical pharmacology & pharmacokinetics (CPPK) team on 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

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Add a note
Something suspicious? Report this job posting.