Request Expert

PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track record of developing and commercializing regulated products across diverse diagnostic fields of centralized clinical chemistry, point-of-care (POC), molecular diagnostics (MDx) and companion diagnostics (CDx). In-depth knowledge and review on global IVD market. Led the R&D teams to develop and obtain regulatory clearance/approval for 20+ IVD products in the US, EU, Japan, Canada and ROW. A highly accomplished leader and mentor with 8 years of people management experience with increasing responsibility and scope. A strategic and visionary leader with strong sense of urgency, discipline, commitment and organization in a fast-paced environment with regard to commercializing new products and achieving company objectives. In-depth of working experience and knowledge in product development process, quality assurance, quality control and regulatory submission by demonstrating success in leading multiple product development projects from feasibility to launch in CGMP environment. Results-oriented communicator with creative problem-solving skills. Passionate, driven, innovative, strategic and accountable.

Accomplished R&D leader in diagnostic product development, regulatory approval and quality system with RAC (US) Certification. Extensive hands-on experience in FDA 21 CFR Part 800s (Medical Devices), FDA 21 CFR Part 820 (QSR/CGMP), Design Control in QSR, FDA 21 CFR Part 11, ISO 13485, ISO 14971, IVDD (98/79/EC), MDD (93/42/EEC), IMDRF (GHTF), CGCP, CGLP, Pre-IDE, IRB, RUO, IUO, CLIA Waiver, 510(k), PMA, CE Marking, Companion Diagnostics (CDx), CMDR, MHLW, MSDS, OSHA, SOPs, CLSI, NCAR, CAPA, QA, QC, auditing, compliance and regulatory submission. Strong leadership and organization skills in leading cross-functional teams in new product development. Extensive experience and achievements in management of R&D project, OEM partnership, business collaboration with Key Opinion Leaders (KOLs), clinical reference labs for external evaluation or clinical trial and pharmaceutical companies for companion diagnostics. Experienced leader in talent management, people development, team building and cross-functional teamwork. Excellent written and verbal communication skills. Superb organizational skills. Effective presentation skills. Strong computer skills and solid understanding of statistics.

Strong technical knowledge and experience across a broad spectrum of clinical diagnostics with ability to develop expertise in new fields: Real-Time PCR (qPCR) Sample Preparation, DNA/RNA Extraction, bDNA, Primer and Probe Design, DNA Sequencing, Site-Directed Mutagenesis Immunoassay, ELISA, Enzymatic Assay, LC-MS/MS, Chemiluminescence, Fluorescence-Based Technology including Fluorescence Polarization (FP), Fluorescence Resonance Energy Transfer (FRET) and Homogeneous Time Resolved Fluorescence (HTRF), Luminex’s xMAP, Multiplex, Lateral Flow, Magnetic Particles and Beads, Calorimetry including Isothermal Titration Calorimetry (ITC) and Differential Scanning Calorimetry (DSC), Circular Dichroism (CD), Light Scattering, Flow Cytometry, Chromatography, HPLC/FPLC, MALDI, NMR, Electrophoresis, Clinical Systems and Platforms, Instrument Automation, Product Design, Assay Formulation, Assay Optimization, Assay Standardization, Assay Traceability, Assay Verification, Assay Validation, Stability, Risk Assessment (FTA and FMEA), Design Change Control, Scale-Up, Product Transfer, Process Validation, Clinical Trials.