Shuvojit Banerjee Email & Phone Number

Rockville, Md, Us

Rockville, Maryland, United States

United States

Supervise a team of nine (9) + individuals focused on Drug Product Release and Stability for Phase I through Phase III products. Lead development of fast-track analytical methods is supporting Process Development and Characterization and Manufacturing.• Analytical development strategies for cell and gene therapy products and viral vaccines from Kick-off to close out.• Developed proposal as per client needs• Developed and implemented strategies to drive technical advancements, optimize processes, and ensure alignment with regulatory requirements.• Performed review activities such as review of analytical methods, protocols and analytical work record.• Design, evaluation and monitoring of stability Programs for drug substances and drug products, post approval stability requirements and statistical analysis. • Partner in efficiency enhancement projects, including establishment of reliability rooms, notebook templates, and new workflows for procedures.• Interact with clients to create phase-appropriate specifications and stability plans, agree upon timelines for scoped work, ensure project progression, and resolve any project-related issues.• Engage in revenue forecasting with a multidisciplinary team (Finance, Project Management, and Technical teams) to ensure communication of changes to project scopes and timing, as well as completion of billable work.• Train and mentor direct reports and guide them in performance of testing and research following USP, GMP, and SOP requirements.

• Lead analytical development, validation, and testing for drug substances and drug products.• Review all data, reports, records, specification, and studies.• Developed and qualify ddPCR/RT-ddPCR based method for cell based products.• Developed and Qualify cell based assay, titer assay, ELISA and Flow cytometry based assay.• Implement and maintain trending of reference standards, assay controls, and assay performance.• Contribute to or lead technical departmental and cross-functional process improvement initiatives• Lead technical departmental and cross-functional process improvement initiatives.• Engage in revenue forecasting with a multidisciplinary team (Finance, Project Management, and Technical teams) to ensure communication of changes to project scopes and timing, as well as completion of billable work.

Rockville, Maryland, United States

▪ Responsibility: Built and analyzed oncolytic viruses using molecular virology techniques in molecular virology projects▪ Research: Performed complex assays, tests, and studies: DNA/RNA purification, restriction enzyme digests, PCR, ligation reaction, bacterial transformation and culture, co-transfection of cell lines, viral selection, plaque purification, and propagation of virus and plaque assays

Cleveland, Ohio

Assistant Professor▪ Teaching: Taught students in Molecular Medicine program ▪ Troubleshooting: Troubleshot complex problems in creative and effective ways as needed▪ Innovation: Actively participated in innovation and optimization of established processes ensuring project goals achieved▪ Writing: Wrote protocols and federal grants

Rockville, Maryland

Project Scientist▪ Collaboration: Collaborated with principal investigator; successfully managed projects and collaboration▪ Independent Investigation: Worked independently within scientific framework of principal investigator's laboratory▪ Mentoring: Supported Technicians, graduate, and undergrad students and post-doctoral fellows by spending 90% active time in laboratory, and provided hands mentoring ▪ Lab Member and Collaborator: Functioned effectively as both a lab member and collaborator▪ Grant Writing: Wrote grant proposal winning funding from extramural sources supporting research projects ▪ Publication: Published high-impact paper in Proceedings of the National Academy of Sciences of the United States (PNAS)▪ Tumor Biology Model: Designed and developed tumor biology model and translational research resulting in understanding mechanism of action ▪ Cancer Chemo and Immunotherapy: Led preclinical efficacy for cancer chemo and immunotherapy ▪ Drug Recovery Programs: Supported drug discovery programs by providing relevant scientific and strategic input to project teams regarding relevant biomarkers and pharmacodynamics model▪ Assay Validation: Designed, executed, and validated a variety of assays, building heightened understanding of target of interest and characterize biological prototypes▪ Efficacy Studies Data: Developed and conducted in vitro and ex vivo mechanism of action studies supporting data for efficacy studies ▪ Patent: Submitted US Patent application ‘Cancer Treatment Methods and Compositions’

Cleveland, Ohio

Scope: Conducted research under mentorship of principal investigator in predominantly independent manner.▪ Hypotheses Testing: Tested hypotheses by developing experimental designs, managing and processing data, and interpreting and preparing results for publication in peer-reviewed journals▪ Administration: Organized departmental journal club to educate graduate and Post Doc fellow about cutting edge research in Cancer biologyResearch Duties: ▪ RNA Analysis: Regularly analyzed small RNAs from viruses; infected cells transfect small RNAs in mammalian cells▪ Immune Cell Function: Participated in innate immune cell function and cytokine release assays (ELISA) mammalian cell culture▪ Virology Techniques: Propagated viruses (Vaccina virus, HSV-1, influenza A, VSV, EMCV, MHV) in mammalian cells viral titration-plaque assay, IFN antiviral bioassayResearch Results:▪ Achievement: Received certificate of achievements from the Department of Cancer Biology▪ Gene Cell Lines: Developed gene knockout cell lines using CRISPR-Cas9 system; developed gene knock-in cells▪ Mammalian Cell Lines: Develop mammalian cell lines (including stable cell lines, knock out and knock-in, and immortalization of primary cells) ▪ Training: Developed, maintained, and trained colleagues on both established and novel innovative in vivo/ex vivo assays/analyses of immune and tumor cell population▪ Experimentation: Designed and executed experiments, critically interpreted data and provided future directions ▪ Antibody and Cell-Based Therapeutics: Work across multiple groups to develop and evaluate antibody or cell-based therapeutics in oncology indications and drive their preclinical evaluation ▪ Efficacy Testing: Developed assays and models for efficacy testing and led selection of immuno-oncology approaches and combination therapies▪ Novel Therapeutics: Established and applied in vitro, in vivo, and ex vivo assays and models to identify and characterize novel therapeutics

Cleveland, Ohio

Lerner Research InstituteScope: Conducted research under mentorship of a principal investigator in a predominantly independent environment. Tested hypotheses by developing experimental designs, managing and processing data, and interpreting and preparing results for publication in peer-reviewed journals. Collaborated closely with principal investigator and communicated effectively both in written and in oral presentations. Managed and published papers in peer-reviewed journals. Established high throughput reporter-based assay. Project data contributed to NIH RO1 grant.PI: Robert H.Silverman

Cleveland, Ohio

Lerner Research InstituteScope: Conducted research under mentorship of a principal investigator in a predominantly independent environment. Tested hypotheses by developing experimental designs, managing and processing data, and interpreting and preparing results for publication in peer-reviewed journals. Collaborated closely with principal investigator and communicated effectively both in written and in oral presentations. Managed and published papers in peer-reviewed journals. Established high throughput reporter-based assay.PI: Dr. Charles B. Foster

Doctor Of Philosophy, Biotechnology

Scope: Managed and published papers in peer-reviewed journals. Author of two book chapters. Established 2 new collaborations. Drove.

Bachelor Of Science, Chemistry, Honors

Minors: Mathematics and Physics

Master Of Science, Biochemistry

Concentration: Advanced Microbiology