Location
Ahmedabad | India
Job description
- To plan and conduct metabolite identification studies using samples obtained across species from both in vitro and in vivo DMPK studies .
- Provide Met ID subject matter expertise and support project teams to plan appropriate studies and/or provide interpretation of the results obtained.
- Operate High-Resolution LC-MS instrument (HRMS) and ensure high-quality data.
- Analyse data, summarize results, and present key results, metabolic pathways internally and externally.
- Collaborate with translational medicine, biology, and bioinformatics teams to propose translational biomarkers strategy.
- Expertise in software for proteomics, metabolomics and met ID work
Position:Immunoassay Group
Qualification: Ph. D or MS in Biotechnology / Biochemistry/ Biomedical
Experience 10-15 years
- Sound subjectknowledge of immunology/ pharmacokinetics of biotherapeutics and monoclonalantibodies. Understand the regulatory guidance FDA, EMA and M10 to establishligand binding assays.
- Goodunderstanding on assay design/formats of Immunoassays, Meso Scale Discovery(MSD), Cell based assays, Hybrid LBA-LC/MS assays. Expertise on development andvalidation of PK, immunogenicity, biomarker assays using ELISA, MSD or anyother ligand binding assays.
- Ability toestablish cell based or ligand binding assay for determination of neutralizingantibody (NAb).
- Proficiency insoftware like Laboratory Information Management System (LIMS), statistical softwaressuch Phoenix WinNonlin, GraphPad, SAS and usage of statistical methods fordetermination of cut points, assay sensitivity analysis.
- Profoundknowledge on interpretation of PK and immunogenicity to correlate withnon-clinical and clinical outcome pertaining to PK/PD/safety. Qualitymanagement processes, preparation review SOPs, method validation plans,method validation repots and study reports.
- Ability tocollaborate with cross functional teams, proactive, independent thinker, goodin communication and good interpersonal skills.
Position Metabolite / biomarker Identification andTranslational Research Scientist
Qualification: Ph.D. in Chemistry , Biochemistry / Pharmaceutical Chemistry
Experience 10-15 years
- To plan and conduct metabolite identification studies using samples obtained across species from both in vitro and in vivo DMPK studies .
- Provide Met ID subject matter expertise and support project teams to plan appropriate studies and/or provide interpretation of the results obtained.
- Operate High-Resolution LC-MS instrument (HRMS) and ensure high-quality data.
- Analyse data, summarize results, and present key results, metabolic pathways internally and externally.
- Collaborate with translational medicine, biology, and bioinformatics teams to propose translational biomarkers strategy.
- Expertise in software for proteomics, metabolomics and met ID work
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