Sciex-Analyst
KISHAN RANJAN SAHOO
DMPK SCIENTIST
Hyderabad
Summary
Results-driven professional with over 14 years of progressive experience in DMPK, bioanalytical R&D, and advanced analytical platforms, including LC-MS/MS, LC-HRMS, and RapidFire-HRMS. Proven track record in optimizing analytical workflows and establishing robust validation frameworks to enhance operational efficiency. Expertise in maintaining audit readiness within FDA, EMA, and GLP-regulated environments, supported by a strong foundation in scientific principles and regulatory compliance. Proficient in PK profiling, ADME studies, and metabolite identification, contributing to the advancement of drug development processes.
Overview
3
3
Languages
15
15
years of professional experience
Work History
Principal Scientist
Syngene International Ltd.
10.2021 - Current
- Oversaw high-throughput LC-MS/MS,LC-HRMS,RF-LCMS,HPLC-UV method development for bioanalysis in ADME studies.
- Acted as primary contact for client-facing DMPK studies, overseeing all requests until report completion.
- Independently perform and oversee analysis of diverse biological and formulation matrices generated from ADME and PK studies, ensuring accuracy, reproducibility, and compliance with GLP and internal quality standards.
- Supervised DMPK bioanalytical team operations, prioritizing effective project execution and timely data release.
- Addressed chromatography and mass spectrometry issues through technical troubleshooting, improving efficiency.
- Collaborated with in vitro ADME teams to enhance bioanalysis workflows for increased productivity. Scheduled regular maintenance and calibration of HPLC/LC-MS systems per regulatory requirements for reliability.
- Mentored junior team members in technical skills while reinforcing best practice compliance.
- Prepare, review, and maintain analytical protocols, method development reports, validation reports, templates, and study documentation, ensuring compliance with GLP, data integrity (ALCOA++), and organizational quality systems.
- Maintain strict adherence to safety, quality, and compliance policies, contributing to a strong culture of regulatory readiness and scientific excellence.
- Demonstrate effective communication with internal and external stakeholders, addressing scientific queries, clarifying analytical findings, and supporting informed decision-making.
Scientist IV
Navitas Life Sciences (Ecron Acunova)
09.2018 - 10.2021
- Owned regulatory documentation frameworks including validation protocols, bioanalytical plans, and standard training protocols for smooth operation of bioanalytical processes.
- Directed method development and validation processes ensuring FDA/EMA readiness for global study programs.
- Streamlined documentation review workflows resulting in a reduction in approval turnaround time.
- Operated instruments like Waters MS/MS (XEVO TQS) coupled with Waters I-class HPLC.
Senior Executive
Micro Labs Limited
07.2016 - 09.2018
- Reviewed bioanalytical study plans, protocols, method validation reports, and bioanalytical reports, and communicated with CROs for overall regulatory compliance.
- Ensured regulatory compliant LC-MS/MS operations supporting multiple clinical and preclinical submissions.
- Coordinated with CROs and QA units to resolve compliance gaps and documentation discrepancies.
- Operated instruments like API 4000 and 5500, LC/MS/MS (Sciex) coupled with H.P.L.C. (Shimadzu).
Senior Research Associate
SITEC Labs
10.2013 - 07.2016
- Executed validation and study sample workflows under strict regulatory guidelines ensuring audit-ready execution.
- Maintained calibration programs and documentation systems aligned with regulatory inspection requirements.
- Enabled smooth regulatory audits by creating structured SOPs and traceability systems.
- Processed development, validation, and study samples using techniques like LLE, SPE, and protein precipitation with compliance of regulatory requirements.
Analyst
Raptim Research Ltd.
07.2011 - 10.2013
- Performed method development and validation with zero data-integrity deviations across multiple projects.
- Maintained equipment qualification records and coordinated data flow between bioanalytical and clinical units.
Education
M.Pharm - Pharmaceutical Analysis & Quality Assurance
BPUT
B.Pharm - undefined
BPUT
Skills
High-Throughput Screening (HTS) Setup
LC-MS/MS, LC-HRMS & RapidFire-HRMS Expertise
Regulatory Strategy & Compliance for Bio analysis in clinical trials
Method Development & Scientific Review
Software
Agilent Mass Hunter
Waters MassLynx
Timeline
Principal Scientist
Syngene International Ltd.
10.2021 - Current
Scientist IV
Navitas Life Sciences (Ecron Acunova)
09.2018 - 10.2021
Senior Executive
Micro Labs Limited
07.2016 - 09.2018
Senior Research Associate
SITEC Labs
10.2013 - 07.2016
Analyst
Raptim Research Ltd.
07.2011 - 10.2013
B.Pharm - undefined
BPUT
M.Pharm - Pharmaceutical Analysis & Quality Assurance
BPUT
SOFT SKILLS
- Cross-functional collaboration
- Time & project management
- Adaptability in regulated environments