Yogesh Patel Email & Phone Number

Adelaide, Sa, Au

Adelaide, South Australia, Australia

• Strategic planning and scientific oversight of method development and validation for PK, Anti-Drug antibody & neutralizing antibody assays in support of biosimilar & novel biologics program.• Conceive, plan and lead R&D & innovative techniques focused on development of complex ligand binding assays across different biological matrices whilst adhering to regulatory guidelines.• Evaluating emerging technologies & communicate scientific data to study directors and analytical team for troubleshooting and supporting development of highly tolerant and sensitive immunoassay method.• Collaborate with global teams and manage client interactions to deliver strategies that support clinical and non-clinical studies through robust and reliable bioanalytical methods.

Hyderabad, Telangana, India

• Study personnel & Project in-charge for planning and execute project study plan for PEGylated drug INDs.• Access to the study plan and SOPs for bioanalysis and responsible to comply with GLP compliance in lab.• Assist SD in compilation of validation/ study data and preparation of reports & technical documents.• Supporting analytical manager, mentoring scientific staff, assists the group to troubleshoot technical problems and undertaking training on GLP/OECD for team throughout development of assay.• Handling of Watson-LIMS assisted method validation and study sample analysis as per the STPs.• Liaise with collaborator & team representative; prepare timely update and follow-ups with query regarding project progression and timelines along with managing health & safety precautions.• Support Bioanalytical group by assisting resource procurement, assist in equipment calibration and maintain GLP compliance for completing the project objectives.

Bengaluru Area, India

• Accountable for assay development, validation and transfer in line with budget and timeline for exploratory, preclinical and clinical phase I/III studies.• Supervision & performing bioanalytical method for PK/ PD, efficacy and safety evaluation including designing, testing, reporting and presentation.• Responsible for effective CRO relationships to monitor and manage project to support global clinical trial. Liaise with CRO to ensure smooth transition into validation.• Leading facilitation, coordination and alignment with study directors, quality assurance (QA) and collaborating partners in conducting assay development, monitoring validation and sample analysis projects.• Compilation, analysis and interpretation of scientific data using industry standard software and tools viz. Gen5, SpectraMax GxP, GraphPad Prism, JMP SAS with proven accuracy.• Providing training and technical presentation to analytical staff for operation of immunoassay as per recent FDA, EMA, TGA recommendations and guidelines.• Summarization, verification & peer review of in-study data and lab notebooks, authoring and reviewingstandard operating procedures (SOPs) and Analytical Methods.• Proficient with GLP/GCP regulation, quality compliance, LIMS software and data management.• Experienced in PK, ADA & NAb method transfer activities to GLP lab setup viz, Covance laboratories,Harrogate (UK), PPD laboratories LLC (USA) to support IND & BLA filing.

Bengaluru, Karnataka, India

• Develop, qualify and manage in-house bioanalytical methods (ELISA and ECL based assays) to supportpreclinical, global clinical trial, manufacturing and batch release projects. • Development of assays for establishing bio-similarity between innovator and biosimilar mAb based therapeutics.• Perform routine lab operations, sample extraction, preparing reagents & buffers, calibration and performance check of colorimetric and electro-chemiluminescence plate readers.• Proficiency in affinity based protein purification for anti-Id antibody, human IgG and IgA through ÄKTA Prime plus.• Highly skilled in conjugation, tagging and coupling of biomolecules with varieties of detection system.• Successful tiered immunogenicity assay Method transfer to Syngene International Ltd for mAb biosimilar in to support clinical sample analysis.• Performed ability to independently design batches and effectively implement experiments in a timely manner.

Bengaluru, Karnataka, India

• Hands-on training for Ligand binding assay.• ELISA assay development and data analysis.• Bioanalytical validation overview and requirement.• LBA based method qualification for Pharmacokinetic (PK) assessment of Bevacizumab biosimilar to support preclinical study.

Kalyani, West Bengal, India

• Worked in a project for functional characterization of interaction of poly (ADP-ribose) polymerase-1 (PARP1) with telomere binding proteins. • Identified and characterize PARP1 and Telomere binding proteins in HeLa & U2 OS immortal cell lines.• Investigate functional interaction of Poly (ADP-ribose) polymerase1 with other DNA proofreading and repairing factors through TRAP, TIF assay, PCR and RT-PCR.• Performed routine passage of animal cell lines and transfection with RNA.• Ensured consumable inventory for smooth performance of experiments and generate required data. • Extensive literature search and schedule work plan to resolve problems related with research.• Hands on experience in SDS-PAGE, western blotting, microscopy analysis at and its interpretation.

Master Of Science, Biotechnology

Bachelor Of Science, Biotechnology (Hons.)

Higher Secondary, Bio- Science