Hiring for Clinical Biopharmaceutics Hyderabad for Exp. 7 - 9 Years at Dr. Reddys Laboratories Ltd..
Hyderabad, Telangana, India
Nov 17, 2017
General Admin, Others
Job Description:Role : Scientist Reporting to : Director Location : Bachupally 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 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 Educational & Experience: Ph.D./MPharm with 5 to7 years of experience in Formulation/Biopharmaceutics Who may apply: We are fine to evaluate Formulation scientists interested to work in Clinical Team. Analytical Formulation Scientist - Please do not apply.