Phd & Pharma Research Scientist Post @ Jubilant
Phd & Pharma Research Scientist. Research Job. Application is invited along with complete bio-data for the one post of RS in Analytical Research project. Interested and Eligible candidates may apply Online. Check out all the details on Rasayanika.com. All the latest jobs related to chemistry & Pharma can be found.
Job Title: Research Scientist
Qualification: P.hD /M Pharma
Experience : 3 to 6 years
- Literature review, collation of published pharmacokinetic (PK) data and development of bio strategy notes/document for pipeline projects
- To oversee development, review and finalization of pilot and pivotal BE protocols and support regulatory team (DRA) for timely application of local regulatory permissions (BE NOCs/T-BE-licences)
- Planning and execution of BE studies
- Coordination with Plant and R and D teams for timely delivery of the investigational products (IPs)
- Monitoring of pilot and pivotal BE studies sponsored by Jubilant Generics Limited
- Ensuring timely receipt of BE reports, reviewing the same prior to submission to the regulatory team (DRA)
- Computation of pharmacokinetic and statistical analysis using WinNonlin software
- Reviewing the BE data for the planning of further studies. This includes analysis of PK data so as to make appropriate recommendations to the formulation development team
Identification of discriminatory/bio-relevant dissolution media, whenever possible based on the availability of pertinent data
- Development of appropriate in vitro in vivo relationship/correlation (IVIVR/IVIVC) using a variety of methodologies whenever this is required and is considered feasible
- Provide support in preparation of responses to BE deficiencies received from various regulatory agencies for filed dossiers.