Ashutosh Gavali

Strategic Bioanalytical Leadership & Client Management

• Strategic Single Point of Contact (SPOC): Serve as the primary technical and strategic link for high-value global clients, managing end-to-end communication and aligning bioanalytical deliverables with business objectives.
• Cross-Functional work: Partner with Project Management and Business Development teams to assess study feasibility, develop precise costing models, and drive commercial success for complex bioanalytical programs.
• Subject Matter Expertise (SME): Act as part of the lead technical authority for Pharmacokinetics (PK) bioanalysis at the Bangalore site, providing expert oversight of the bioanalysis front.
• Client Relationship Management: Lead weekly technical meetings for few clients, ensuring transparency on timelines, troubleshooting complex hurdles, and maintaining a high standard of routine study execution.

Core expertise in Bioanalysis

Managed a team of 7 scientists to create bioanalytical methods for complex analytes.

Ø Lipid Nanoparticles (LNPs) Vaccine analysis- Spearheaded the development of complex analytical methods for active ionizable lipid and vaccine excipients.

Ø Liposomal formulations, including specialised method development for Total, Encapsulated, and Free analyte estimation.

Ø Prodrug-drug Bioanalytical method development setup for high throughput PK’s.

Ø Derivatization techniques for poorly ionizable compounds

Ø Chiral separations for high-throughput PK evaluations, which are used as decision making of lead compounds. (For toxicity profiling of lead compound).

Ø Biomarker method development via surrogate matrix and high-throughput approaches.

• Guiding a team of 6 scientists for Method Development, Method Validation, and Study sample analysis.
• To plan and conduct bioanalysis as per USFDA, ANVISA, EMEA regulatory guidelines, and sponsor requirements.
• Guided team for over 50+ studies and method validations submitted for regulatory submissions.
• Responsible for method development on LC-MS/MS (SCIEX 6500+, SCIEX 4500) for meeting sensitivity and reproducibility of the method, developing a rugged method to meet timelines.
• To understand the bioanalytical requirements of the sponsor, to coordinate with the report and bioanalytical team.
• Provide the data as per the requirement of the sponsor.
• Planning and coordinating with the team for bioanalysis.
• Accountable for Completion of projects within the stipulated timeframe.
• Planning, implementation, and review of calibration of various equipment used in the lab.
• To review raw data of sample processing, Chromatographic data, quantification, method validation, and study sample analysis as per SOP and protocols.
• Responsible for review method validation report, and bioanalytical study report as per regulatory submission.
• Respond to sponsor queries regarding the bioanalytical part of method validation and study report.
• Co-ordinating with the inventory team for procurement of reagents, columns, cartridges, and organic solvents for smooth sailing of the bioanalytical project.

• Instruments operation- API-6500, API-4500 (Applied Biosystem) coupled with H.P.L.C.(Shimadzu) / U.P.L.C. (WATERS)Analyst 1.6.4, Shimadzu HPLC.
• Documentation and Communication- Data compilation of method validation and subject study, as per regulatory need and communications with the clinical unit for study samples records.
• Study samples processing- Method development, validation, and study samples by using different extraction techniques which include LLE, SPE (Positive and Negative) protein precipitation with compliance of regulatory requirements.
• Development of critical molecules- with different natures like Steroids and vitamins.
• Calibration and Maintenance- Calibration and maintenance of micropipettes, pH meter, Analytical Balance, and Cooling Centrifuge.

• Bioanalytical method development and Validation for NCEs using LC-MS/MS, for application to Pharmacokinetic studies in, Mice and Rats according to regulatory guidelines.
• Drug tissue distribution studies, Expertise in developing methods in the different matrices, e.g. Plasma, Blood, Liver, Lung, Kidney, Urine, Faeces, Brain, Eye, and Skin.
• Method development and sample analysis for Cell-based assays like CaCO2, Pampa, MDCK, CYP, Solubility, Uptake assay, and Stability assay.

• Instruments operation- API-4000, API-3200, API-3000 LC-MS-MS (Applied Biosystem) coupled with H.P.L.C.(Shimadzu) / U.P.L.C. (WATERS)Analyst 1.6.1.
• Documentation and Communication- Data compilation of method validation and subject study, as per regulatory need and communications with the clinical unit for study samples records.

• Method development, validation, and study samples by using different extraction techniques which include LLE, and SPE as per regulatory compliance.
• Data compilation of method validation and subject study Analysis.