As a seasoned expert with over 23 years in the life sciences sector, I specialize in biocompatibility and Extractables & Leachables (E&L). At B. Braun Medical, I led transformative changes in E&L testing and primary packaging processes, enhancing efficiency and compliance. My early work at Johnson & Johnson involved crucial biocompatibility qualifications for FDA approvals, setting a strong foundation in regulatory compliance. My career has spanned leadership roles at renowned firms like Ferring Pharmaceuticals, Merck Serono, and Debiotech, where I've built a robust network of industry partners. I excel in driving projects from development to lifecycle management across various commercial medical devices and drug products, ensuring safety and robustness at every stage.COMPETENCIESTop 5 Clifton Strengths• Arranger• Connectedness• Achiever• Adaptability• CommunicationMAIN DEVICE & COMBINATION PRODUCTS Implantable Pump and accessories (Neuroscience).Patch Pump and accessories (Diabetes and Fertility).Primary Packaging, such as stopper, glass and plastic vials, plastic bag and bottle, prefilled syringe, port systems, primary labels (Hospital Care various Injectable Drugs and Nutrition)Auto-injectors (Mechanic and Electronic for various Hormonal Therapeutic Areas)Prefilled Pens and Syringes (Fertility and Oncology)Nasal Sprays (Urology)Reconstitution, Connector and Vial Adaptor Devices (Oncology)Software as Devices (Fertility)Coated Catheter Hydrocephalus Valve (Neuroscience).Topical Devices (Hormone)Operational/Technical Expertise• Manufacturing Tech Transfer • Safety Risk Assessment• Human Factor Studies• E&L and Biocompatibility• Primary Packaging• Medical Device• Combination ProductCross-functional culture• Networking • Project Management• Life Cyle Management• Quality QC/QA• Regulatory • Manufacturing• Supply Chain • Procurement MAIN DEVICE & COMBINATION PRODUCTS