Bio

Highly proficient professional with 15+ years’ experience as a scientist/manager in the biotechnology and biopharmaceutical industry with a proven track record of delivering results. Extensive lab hands-on and management experience. Self-motivated with strong attention to detail and organization skills; excellent analytical, critical thinking, troubleshooting and problem solving skills. Strong interest in new knowledge and technology. Accomplished scientist with broad assay development, QC/QA and research discovery in biotechnology and bio-pharmaceutical industry in positions of increasing responsibility. • 10+ years in assay development for diagnostic bio-markers, drug manufacturing process related impurities assays and a phase II/III immuno-oncology humanized antibody drug potency assay; specialized in assay design, development, optimization, qualification, validation, technical transfer and commercial product development. 10+ years in GXP-compliant working environment. • 5+ years of experience in oncology gene discovery and function characterization. • Extensive experience in CMO/CRO, project and lab management. • Expertise in QC/QA & Regulatory related work: multiple successful 510(k) and IND submission, QbD experience, extensive knowledge with FDA, EMA, GXP, WHO, CLSI, ISO and ICH regulatory requirements.