Research Scientist

Job Description

1.Collate and present literature review on preformulation, physico-chemical characterization, stability, bioavailability/pharmacokinetics of molecules to aid complex generic product development. Application of fundamental understanding of Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics & Biostatistics in generic formulation design.
2.Lead the effort towards reconstruction/ reverse engineering of innovator formulation including preformulation studies, evaluation of API & in-house formulation using modern analytical, imaging and characterization techniques.
3.Responsible for brain storming with team and clarification of ideas aimed at development of discriminatory and bio-relevant dissolution methodologies, review and validation of data generated from this effort with the objective of providing the formulation team tools that aid in systematic deduction of formulation variables and improving the BE hit rates.
4.Supervise & perform preformulation studies for complex generic formulations and develop innovative methods to perform RLD characterization studies to aid development of formulation/manufacturing strategies for complex generic products.
5.Lead the team in developing prospective in vitro/in vivo model for new projects- Connecting RLD design and reported in vivo (PK) results to build targeted dissolution profile & dissolution methodologies before initiation of actual development.
6.Perform retrospective/ prospective biopharmaceutical modeling of in vitro/in vivo data of complex generics with an objective of establishing IVIVR/C. Dissection and meta-analysis of pilot/ pivotal BE data- Using systematic deduction & statistical approaches.
7.Document methods and results from dissolution studies, biopharmaceutical modeling, preformulation studies and RLD characterization experiments. And to prepare reports/presentations for project discussions with the formulation development group

Work Experience

PhD with 3-5 years experience/ Fresh PhD/ Post Doc in Pharmcokinetics (PK) and Biopharmaceutics to consider as M1

Education

Competencies