Cloud-native, AI-first SaaS platform that guides, de-risks, and accelerates MedTech’s New Product Development, and drives quality compliance to achieve a desired ROI.

SCIEX— a Danaher operating Company.DBS, QARA activity from product ideation to launch/ commercialization. Quality Domain Lead for New Product Introduction. Design/ Manufacturing Tech Transfer. FDA / Notified Body audits.

Quality Analytics and Distribution Operation Champion for Class 3 Medical Device.

Owned Quality Systems /RecordsChampioned operational excellenceSample management via LIMSDesignated Subject Matter Expert (SME) on over 90% of the Plant's Laboratory testing)

Routine microbiology testing, Root Cause Analysis, Equipment & Process Validation, Trending Analysis, GAP analysis, CAPAsAuthored over 24 SOPs, technical reports, IOPQ Validation reportsChampioned operational excellence & Lean Sigma initiatives & deliverables

• Executed assay development, validation, and clinical integration for various nucleic acid and protein based biomarkers with respect to mutations and hypermethylation• Contributed in the “Development of a real-time multiplex PCR assay for the detection of FGFR3 mutations in Urine and Tissues;” final product was presented at the AACR Annual Meeting and Genitourinary Cancer Symposium, 2011• Exceeded timeline expectations in securing target assay specificity and sensitivity• Contributed in the manufacture of and perform in-process QC of components for DNA and protein based diagnostic assays• Prepared analytical reports, presented data to colleagues, and contributed to several SOP developments• Technical Skills:o GLP Environment, Roche qPCR, DNA/RNA quality assessment, DNA/RNA extraction and purification, analysis of qPCR DATA, Protein Purification, ELISA, Western Blot

• Led the optimization of DNA extraction for percent yield, concentration, and quality assurance for the development & validation of an IVD assay for a clinical trail• Designed mathematical proofs of test cases and documented in lab notebook; executed verification and validation tests for the medical device software that accompanies the developed assay for a clinical trial • As part of the Cambridge NIBR internship program, attended seminars and workshops, and presented project findings at the end of the program’s poster sessions • Prepared analytical reports, presented data to colleagues, and contributed to several SOP developments • Technical Skills:o GLP/GMP environment, High Throughput DNA Isolation/ Robotics/LIMS, RT-PCR, Qiagen Automated qPCR, DNA/RNA quality assessment, DNA/RNA extraction and purification, analysis of qPCR DATA, mammalian tissue culture, Primer & Plasmid Design, ELISA

• Conducted undergraduate thesis on effects of T-bet (a transcription factor associated with T cells) expression in dendritic cells on controlling the movement of mast cells into the lungs with allergic inflammation• Participated in the Dana Farber/Harvard Cancer Center Continuing Umbrella Research Experience (CURE), that resulted in the publication of an abstract in CURE’s scientific presentation pamphlet in August of 2009• Presented research findings to Dana Farber/Harvard Cancer Center scientific community• Published manuscript in Framingham State College’s Journal of Critical Thinking