Anupkumar Thakkar
Gaithersburg,MD
Summary
- Accomplished Bioanalytical Lead Scientist with extensive experience in the development, validation, and execution of bioanalytical methods supporting preclinical and clinical studies.
- Expertise in LC-MS/MS, HPLC, UPLC, and a wide range of extraction techniques including protein precipitation, liquid-liquid, and solid-phase extraction.
- Proven ability to lead method development projects, manage cross-functional teams, and ensure regulatory compliance with GLP, cGMP, and international guidelines (FDA, EMA, ICH).
- Skilled in troubleshooting analytical issues, optimizing workflows, training junior scientists, and ensuring timely data delivery aligned with project milestones.
- Strong collaborator and communicator, adept at working with internal stakeholders, sponsors, and quality teams to drive successful outcomes in bioanalytical operations.
- Hands on experience with protein characterization using various analytical techniques such as Capillary Electrophoresis, ELISA and qPCR.
Overview
14
14
years of professional experience
Work History
Lead Scientist, Bioanalytical
Pharmaron (Germantown) Lab Services, Inc.
08.2023 - Current
- Collaborate with bioanalytical scientists in the execution of LC-MS/MS assay development, validation, and sample analysis.
- Oversee experimental design, execution, data interpretation, and report generation in coordination with study sponsors.
- Perform Principal Investigator (PI) duties, acting as the primary contact for sponsors on assigned studies.
- Host regular client teleconferences and support sponsor communications, including protocol and document review.
- Assist in training personnel on maintenance, operation, and troubleshooting of laboratory equipment.
- Track project timelines and ensure the timely delivery of client commitments.
- Participate in data transfers and support both pre-clinical and clinical data management tasks.
- Ensure laboratory practices align with company SOPs and safety policies.
Process Development Senior Scientist, Analytical Services
BioVectra Inc.
03.2018 - 07.2023
- Develop and troubleshoot advanced bioanalytical chromatographic methods to support biologics process development.
- Establish and optimize intact protein identification and peptide mapping workflows using Q-ToF mass spectrometry for in-depth biologics characterization.
- Design, develop, and validate qPCR assays for detecting residual host cell DNA in biologics.
- Lead the technical transfer of bioanalytical methods from sponsors to internal teams, ensuring seamless integration into biologics development workflows.
- Provide regular training and mentorship to technicians, students, and scientists on the use and maintenance of analytical instrumentation.
- Draft detailed analytical development reports to document method development, optimization, and troubleshooting findings.
- Collaborate closely with the Quality Projects Group to ensure successful and compliant tech transfer of analytical methods.
- Actively participate in process investigations, providing rapid and reliable analytical support to aid root cause analysis and resolution.
- Lead troubleshooting efforts for analytical anomalies, ensuring minimal disruption to biologics development activities.
Senior Scientist, Bioanalytical
Sannova Analytical Inc.
10.2011 - 01.2018
- Serve as a key technical resource for the development and troubleshooting of analytical and bioanalytical LC-MS/MS methods, ensuring robustness and regulatory compliance.
- Design, develop, and optimize LC-MS/MS methods for the qualitative and quantitative analysis of small and large molecules.
- Conduct thorough investigations of laboratory failures, identifying root causes and drafting detailed laboratory failure investigation reports.
- Collaborate closely with laboratory scientists to resolve complex issues related to method optimization and instrumentation troubleshooting.
- Perform routine calibration, preventive maintenance, and troubleshooting of HPLC and UPLC systems to ensure consistent instrument performance.
- Ensure adherence to current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP), keeping practices aligned with evolving regulatory standards.
- Conduct timely reviews and updates of laboratory Standard Operating Procedures (SOPs) to maintain procedural accuracy and regulatory compliance.
Scientist, Bioanalytical
Sannova Analytical Inc.
03.2011 - 09.2011
- Perform bioanalysis of clinical and pre-clinical samples using advanced extraction techniques—including protein precipitation, liquid-liquid extraction, and solid-phase extraction—on LC-MS/MS systems, with strict adherence to GLP and cGMP regulations.
- Analyze analytical samples for assay and impurity profiling using HPLC and UPLC systems, ensuring data integrity and regulatory compliance.
- Operate and maintain critical analytical instrumentation including HPLC, UPLC, LC-MS, and ICP-MS, along with their associated data acquisition and processing software.
- Process analytical data related to sample analysis, identify outliers or repeat requirements, and ensure timely and accurate reporting of results.
Education
Master of Science - Chemistry
Fairleigh Dickinson University
Teaneck, New Jersey01.2011
Bachelor of Pharmacy - undefined
Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka01.2008
Skills
- LC-MS/MS
- Bio-analytical Method Validation
- Bioanalysis
- Troubleshooting
- HPLC / UPLC
- SEC / HILIC
- ELISA
- Capillary Electrophoresis
- qPCR
- Sciex Triple Quad 5500, 6500
- Waters Xevo G2-XS QToF
- ICH M10 Bioanalytical Method Validation and Study Sample Analysis guidance
- GLP and GCP regulations
- cGMP
Timeline
Lead Scientist, Bioanalytical
Pharmaron (Germantown) Lab Services, Inc.
08.2023 - Current
Process Development Senior Scientist, Analytical Services
BioVectra Inc.
03.2018 - 07.2023
Senior Scientist, Bioanalytical
Sannova Analytical Inc.
10.2011 - 01.2018
Scientist, Bioanalytical
Sannova Analytical Inc.
03.2011 - 09.2011
Bachelor of Pharmacy - undefined
Rajiv Gandhi University of Health Sciences
Master of Science - Chemistry
Fairleigh Dickinson University
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