Jubilant Generics LimitedRecruitment August 2020. Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.
Important Vacancy details:
- Post Name: Research Scientist-Medical Affairs(PK/PD)
- Education: P.hD /M Pharma
- Location: R&D Centre – II, IND,Noida
- Salary : NA
- Openings :NA
Job Description: We have requirement for the post of Research Scientist-Medical Affairs(PK/PD) in Jubilant Generics Limited !
- 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&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 regulatory team (DRA)
- Computation of pharmacokinetic and statistical analysis using WinNonlin software
- Reviewing the BE data for 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
Selection Process: The selection will be on the basis of Interview.
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