Yogesh Patel Email & Phone Number

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.

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.

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.

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.

Master Of Science, Biotechnology

Bachelor Of Science, Biotechnology (Hons.)

Higher Secondary, Bio- Science