Navin Varshney Email & Phone Number

Rahway, Nj

Screening and Protein Sciences, Drug Discovery• Provided chemical validation support including identification, characterization, and assessment of potency of novel impurities and degradates for active pharmaceutical compound transitioning from Discovery to Development.• Participated on a performance monitoring committee under the Lead Identification strategy team to actively identify and analyze active and inactive compounds in Merck’s compound collection.• Responsible for developing a data analytics tool to capture the results of all chemical and biological testing from potency confirmation to in-depth validation and identify potential markers of success or failure of compounds in the process.• Member of Merck’s New Technology Research Leadership Committee, responsible for assessing gaps in high throughput chemical analysis workflow and identifying innovative technology to bridge gaps.

Summit, Nj

Chemical Technologies, Drug Discovery• Launched improved data analytics workflow by customizing an off-the-shelf software application to semi-automate analytical data decision making. Project involved database design, synchronizing results with high throughput chemical analysis application, and data visualization reporting.• Conducted peptide and de novo sequencing for samples provided by Protein Chemistry team to support protein production screening.

Groton, Ct

Exploratory Medicinal Sciences, Drug Discovery• Supported 300 medicinal chemists performing analytical qualitative/ semi-quantitative assessment for combinatorial chemistry libraries. Guided validation of chemical synthesis or identification of degradation pathways relevant to medicinal chemists seeking clinical candidates. • Collaboratively isolated, separated, elucidated and confirmed chemical structures of pharmaceutical samples, with focus on small molecules, as well as low-level quantitation to determine structure activity relationship.• Participated on a steering committee focus group engaging with external pharmaceutical collaborators in developing quantitative analytical methods for studies to determine effects of long-term storage on integrity or compound library for ultra-high throughput screening.

Farmingdale, Ny

Bioanalytical R&D Department• Conducted pharmacokinetic and pharmacodynamic studies as part of DMPK team in support of Celexa NDA and follow up FDA drug submission for approval of Lexapro in the SSRI drug class.• Responsible for preparing bioavailability and bioequivalence studies and reporting as part of Lexapro IND submission.

Garden City, Ny

• Performed stability testing of Percocet and Percodan analgesic products to support FDA inspections and ANDA submissions, following GMP and departmental SOP requirements.

Ma, Biological Science

Relevant Course Work: Graduate Biochemistry, Molecular Genetics, Cancer Biology

Graduate Certificate In Clinical Investigations-Online

Relevant Course Work: Regulatory and Compliance Issues, Designing Clinical Research Studies, Good Clinical Practices

Bs, Biochemistry

Conducted research in the Division of Nephrology/Hypertension, Department of Infectious Diseases at the Graduate Health Science Center..