Michel E. Moravia, Mba, Mse Email & Phone Number

Boston, MA, US

Boston, Massachusetts, US

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.

Boston, Massachusetts, US

Tampa, Florida, US

Burlington, Massachusetts, US

Washington, District Of Columbia, US

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.

Washington, District Of Columbia, US

Bad Homburg, Frankfurt, DE

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

Thousand Oaks, CA, US

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

Forchheim, DE

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.
• 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

Basel, Baselstadt, CH

• 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.

US

• 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

Master Of Business Administration (M.B.A.), Health Sector Management | Strategy & Innovation

Master Of Science - Ms, Product Design & Manufacturing Engineering

Bachelor’S Degree, Biochemistry & Mathematics

High School Diploma