I am an experienced leader of global R&D, Technical Operations, Manufacturing, and Supply Chain organizations with an industrial focus in Biotech, Small Molecule Pharmaceuticals, Medical Devices, Packaging/Labeling, Cell and Gene Therapy, as well as Combination Products. In addition, I have broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance, as well as a successful track record of building and leading medium to large functional and matrix teams.
My technical background is focused in automation, facilities buildout, capital projects, global multi-plant leadership, management of CMOs, process development, scale-up, medical device and equipment design, formulation, controlled release systems, quality systems engineering, in vitro & in vivo testing, and drug device combination products.
My specific product technical expertise include: injectable, ophthalmic and oral pharmaceuticals, drug eluting stents, pre-filled syringes, autoinjectors, infusion pumps, patch injectors, transdermal drugs, stent-grafts, aneurysm clips, coils and endovascular deployment systems, craniomaxillofacial fixation systems, catheters and vascular access devices, aesthetics implants and tissue expanders, dermal fillers, hemostats, adhesion prevention systems, nerve guidance channels, sutures and barbed suture systems, bariatric intragastric balloons, and laparoscopic banding systems.
I have extensive familiarity with: numerous analytical techniques, GLP, GMP (IQ/OQ/PQ/PV), ISO, patent process (USPTO / PCT), FDA regulatory guidelines including IND, IDE, BLA, NDA, 510(k), and PMA submissions, EMA, MHRA, CMC processes, design control and ICH, QA/QC procedures and operations, FMEA, Risk Analysis and Risk Management, as well as numerous scientific publications, prestigious scholarships and awards, over 120 patents and applications.
I am proficient with: SigmaStat/Plot, Minitab, StatTools, @Risk, Oracle, SAP, SEM, DSC, TGA-FTIR, EDS, XRD, NMR, FTIR, Raman, uCT, ICP-AES, UV-VIS-NIR, mechanical testing, microscopy and image analysis (NIS-Elements-AR, Image Pro).