Expert Details

Expert in Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain

Expert ID: 733368 Massachusetts, USA

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Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful track record of building and leading medium to large functional and matrix teams.

Strong technical background in automation, facilities buildout, capital projects, global multi-plant leadership, management of CMOs, process development, scale-up, medical device and equipment design, formulation and pre-formulation, development and industrialization of controlled release systems, quality systems engineering, in vitro & in vivo device evaluation, and drug device combination products.

Specific product focus on: drug eluting stents, pre-filled syringes, autoinjectors, infusion pumps, patch injectors (including high viscosity products), transdermal drug delivery systems, stent-grafts, drug eluting perivascular prostheses, aneurysm clips, aneurysm coils and endovascular coil deployment systems, neurovascular stents, craniomaxillofacial fixation systems, catheters and vascular access devices, aesthetics implants and tissue expanders, dermal fillers, hemostats, adhesion prevention systems, injectable drug delivery systems (DDS), oral solid dose (OSD), nerve guidance channels, sutures and barbed suture systems, bariatric intragastric balloons, ocular implants, and laparoscopic banding systems.

Close familiarity with: numerous analytical techniques, GLP, GMP (IQ/OQ/PQ/PV), ISO, patent process (USPTO / PCT), FDA regulatory guidelines including 510(k) and PMA submissions, EMA, MHRA, CMC processes, design control and ICH, QA/QC procedures and operations, FMEA, Risk Analysis and Risk Management.

Numerous scientific publications, prestigious scholarships and awards, over 120 patents and applications.

Specialties: Proficient with: Microsoft Project, Excel, Word, PowerPoint, Outlook, SigmaStat, SigmaPlot, Minitab, StatTools, @Risk, Oracle, SAP, numerous analytical techniques including but not limited to SEM, DSC, TGA-FTIR, EDS, XRD, NMR, FTIR, Raman, uCT, ICP-AES, UV-VIS-NIR, mechanical testing, microscopy (optical and electron) and image analysis (NIS-Elements-AR, Image Pro). Outstanding public speaker.

Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts - Worcester, Massachusetts - Springfield, Massachusetts - Lowell, Massachusetts - Cambridge, Massachusetts - Brockton, Massachusetts - New Bedford, Massachusetts - Hartford, Connecticut - Manchester, New Hampshire - Providence, Rhode Island

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Education

Year Degree Subject Institution
Year: 2013 Degree: Master of Science Subject: Finance Institution: Indiana University
Year: 2012 Degree: Master of Business Administration Subject: Management Institution: Indiana University
Year: 2005 Degree: Master of Applied Science and Engineering Subject: Chemical and Biomedical Engineering Institution: University of Toronto
Year: 2004 Degree: Bachelor of Applied Science and Engineering Subject: Materials Engineering Institution: University of Toronto

Work History

Years Employer Title Department Responsibilities
Years: 2015 to 2016 Employer: Biogen Title: Director Department: Operations Responsibilities: Leading the Drug Product, Medical Device, and Pack/Label Operations as Global Process Owner. Oversight for all internal, external, CMO, and partner manufacturing sites. Responsible for all aspects of industrialization, transfer, scale-up, validation, lean 6-sigma, launch, and commercial manufacturing. Oversight of all manufacturing process initiatives / improvements, deviations, change controls, CAPAs, and investigations.
Years: 2013 to 2015 Employer: Regeneron Title: Associate Director Department: Operations Responsibilities: Head of the Drug Product, Medical Device, and Pharmaceutical Packaging Technical Operations functions. Responsible for building and leading the team, facilities, and production lines, as well as all aspects of regulatory and quality system support, project and capital budgets, development and supply agreement negotiations.
Years: 2011 to 2013 Employer: Regeneron Title: Sr. Manager Department: Operations Responsibilities: Head of the Medical Device organization, including all development, manufacturing, quality engineering activities (Risk management, 820/820.30 design control, ISO 13485, and Part 4). Built and led the group and quality systems, oversaw projects and capital investments, drafting of technical dossiers and face to face interaction with regulatory agencies (EMA, MHRA, FDA).
Years: 2009 to 2011 Employer: Allergan Title: Manager Department: R&D Responsibilities: Built and managed the Aesthetics and Health R&D Departments at Allergan Medical including all internal, partner, and contract research activities and projects. Responsible for laboratory and testing facility buildout, all biomaterials and formulation projects, equipment procurement, project management, and budget. Managed all internal and external (CRO) testing activities through GLP, biocompatibility, and tox studies. Built and led the reverse engineering team.
Years: 2008 to 2009 Employer: Allergan Title: Sr. Engineer Department: R&D Responsibilities: Responsible for building and managing the histopathology, metrology, and molecular cell biology laboratories. Led the team through development of bioassays, quantitative histopathological test methods, and in vivo models. Supported the drafting of technical dossiers for regulatory filings (IND amendments, CMC meetings / briefing documents, sBLAs, CBE30, PMA, 510k, IDEs).
Years: 2007 to 2008 Employer: Surgical Specialties Title: Sr. Engineer Department: R&D Responsibilities: Led the R&D and Manufacturing Engineering sections of the Hemostream (anti-infective dialysis catheter). Managed the team through formulation, coating, and test method development, product and process characterization, PV and scale-up. Led the process development team of the barbed suture project, prepared facilities and systems, process, and design documentation for compliance with ISO 9000, 13485, 14644, 10993, FDA, PMA, and CE mark audits.
Years: 2006 to 2007 Employer: Surgical Specialties Title: Engineer Department: R&D Responsibilities: Led the development engineering team of the AAA Stent-Graft and drug eluting stent (DES) projects developing next generation prototypes. Managed partnership / collaboration with SurModics. Led pilot scale process development and automation work for stent coating and release testing. Responsible for tech transfer to commercial manufacturing. Focus on Class III devices and combination products.
Years: 2016 to 2018 Employer: Avedro Title: Vice President Department: Operations Responsibilities: Developed and led Global Supply Chain, Procurement, Strategic Sourcing, External and Internal Manufacturing, Logistics, and Technical Operations for Drug Substance, Drug Product (Aseptic Filling), and Medical Devices.

International Experience

Years Country / Region Summary
Years: 2005 to 2008 Country / Region: Canada Summary: Pharmaceuticals, Medical Devices, Biotech
Years: 2005 to 2008 Country / Region: United States Summary: Pharmaceuticals, Medical Devices, Biotech

Career Accomplishments

Licenses / Certifications
PMP Certification
6 Sigma Black Belt Certification - Cornell
Genetics and Genomics Certification - Stanford
Publications and Patents Summary
Over 150 patents and applications. Medical devices, combination products, biotech, pharma, methods, uses, and applications.

Language Skills

Language Proficiency
English Native
Russian Native
Spanish Elementary

Fields of Expertise

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