Expert Details
Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
ID: 733368
Massachusetts, USA
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.
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 |
|---|---|---|---|
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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). |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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). |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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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
polymer microsphere, auto-injector, organizational design, engineering statistics, strategic planning, process validation, gene therapy, quality system, contract manufacturing, business strategy, engineering project management, innovation, drug delivery, controlled-release drug delivery, biotechnology, research and development, lean six sigma, supply chain, aseptic pharmaceutical process validation, biomedical device manufacturing, biomedical device