Sanjeev B. Email & Phone Number

Cambridge, Ma, Us

Cambridge, Massachusetts, Us

• Comprehensive Biophysical and Bioanalytical characterization of critical reagents supporting multiple m-RNA therapeutic drugs.• Executed due diligence in the selection, qualification, and management of Contract Research Organizations (CROs), including regular quality evaluations to ensure compliance with scientific and regulatory standards.• Developed and implemented an internal strategy for critical Reagent management - o Procurement strategies for Antibodies and Transgene protein generationo In-house/CRO-based Biophysical characterizationo Standardization of parameters for the Biophysical characterization – CRO vs In-house supporto Budget forecasting and monitoring for the critical reagent resources across multiple projects• Evaluation, feasibility, and deployment of the Freezer/Sample inventory management system. • Managing the lead candidate transition to the next stages, generating validated data, and supporting regulatory filings with Regulatory Agencies.• Managing, mentoring, and coaching the direct reports for the BMA critical reagent support.

Immuno and LCMS-based assay development and validation for clinical and non-clinical programs to support pharmacokinetic and pharmacodynamics of Biotherapeutics (Biologics/Proteins/peptides/oligonucleotides).• Completed multiple PK/ADA/BA projects at various stages of non-clin and clinical development.• Led method/assay development, qualification, and validation of a diverse range of modalities (peptides, proteins, mAbs, ADCs, Bi-specifics, tri-specifics, and oligonucleotides) for the cardiovascular, diabetes, IBD, and immune-oncology disease areas at various stages of pre-clinical and clinical development.• Represented group as PK/PD SME on cross-department and planning teams for co-administration studies conducted with other pharma companies, ensuring efficient and smooth transitioning of project(s) for successful collaboration.• Subject Matter Expert for the biopharmaceutical characterization (aggregation, truncation, PTM’s, deamidation, and glycosylation) of Janssen therapeutics and drug candidates, supporting PK-related issues in all stages of development.• Directed department’s outsourcing efforts for biotherapeutics and small molecules through interactions with CROs, including kick-off meetings, advising on assay design, signing off on validation and Bioanalysis plans, reviewing data, reanalysis planning (if needed), and signing off on final reports.• Streamlined execution and optimization of the Bioanalytical project(s), utilizing expertise in Automation workflows, data regression (Watson-LIMS, GraphPad Prizm, Minitab), and immuno- and MS-based platforms.• Impacted multiple process improvement / new platform development project(s) in the group for further optimization of current workflows/processes collaborating with vendors to bring new technologies and platforms, improving current capabilities, and proactively addressing future needs.

Biomarker Discovery, Protein profiling, Protein Characterization, Assay and Method Development, Qualification, and ValidationImplemented strategic insights for the biomarker projects for the lead optimization in pre-clinical discovery. Recommended and enacted the strategies for the application of proteomics platforms to biomarker studies related to kidney, pancreatic, drug-induced vascular injuries, and oxidative stress. Imparted technical knowledge and hands-on training to colleagues and summer interns in MS, sample preparation, and assay development technologies.

Project Management 360 Certification, Project Management

Ph.D., Analytical Biochemistry

Post Master'S Certification In Regulation Of Generics And Biologics, Regulation Of Biologics/Biosimilars/Generics

M.Sc., Biochemistry

Ms, Management