- Experience in designing, performing, and interpreting metabolite identification studies- Invitro and Invivo.
- Proficient in using LC-MS/MS, HRMS, and other analytical techniques for identification of metabolites and it’s soft spots.
- Ability to analyze complex data sets and structural interpretation for Phase-1, 2, and 3 metabolites.
- Solid understanding of drug metabolism principles and pathway. Experience with regulatory documentation and submissions
- Experience in DMPK concepts and provide insights to project teams. Conduct Bioanalysis of samples from in-vivo pharmacokinetic, tissue distribution studies, PK-PD & TK studies through LCMS/MS
- Represent the group in internal and external meeting. Ability to work effectively in a team environment.
- Strong understanding of various concepts of DMPK in large molecule/ADC with excellent communication skills, driving innovation, managing teams is added advantage
- Responsible for preparation of relevant SOP, protocols, reports, etc. to support various regulatory and non-regulatory submission.