- Read and understand various in vitro ADME protocols
- Conduct in vitro stability (liver microsomes, plasma and in any other relevant matrix, chemical stability) experiments for new chemical entities
- Conduct the following in vitro ADME experiments
- logP, logD, pKa measurements
- CYP induction and inhibition assays
- Permeability determinations (Caco-2, MDCK etc) in relevant cell lines
- CYP phenotyping in purified enzyme systems
- Solubility determinations (kinetic, thermodynamic, simulated fluids)
Bioanalysis :
- Read and understand the bioanalysis sections in the study protocols
- LC-MS/MS and HPLC-UV/PDA method development and validation (partial and complete)
- Developing fit-for-purpose LC-MS/MS methods for routine in vitro sample analysis
- Extracting data from the instrument, conducting bioanalytical QC and sharing of report with the stakeholders within the DMPK department
- Experience in handling bioanalytical method development for various matrices with focus on in vitro samples; understanding to handle plasma, blood, various tissues, urine, faeces etc. is a plus but not mandatory.
- Development LC-MS/MS methods for biochemical and cell based screening of NCEs is a plus but not mandatory
- General LC-MS/MS and HPLC maintenance and troubleshooting
Data analysis and report generation:
- Understand the quality of bioanalytical data
- Conduct data analysis employing Phoenix WinNonLin software is a plus but not mandatory
- Ability to calculate in vitro results/ parameters on excel spreadsheets
- Report generation (excel format, word format and PowerPoint presentation) and sharing with the line manager
Generate reports in both GLP and non-GLP formats (based on the requirement)
Person Profile
Qualification: -
- M.Sc /M.Tech (Biochemistry, Pharmaceutical Chemistry, Biotech background)
- Master in Pharmacy (M.Pharm)
Experience: -
- 2- 6 years of relevant experience.
- Experience in a drug discovery industry/ CRO in DMPK department.
