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Click here or scroll down to respond to this candidateCandidate's Name
8 Manners AvenueSeymour, CT Street Address
PHONE NUMBER AVAILABLE EMAIL AVAILABLEhttps://LINKEDIN LINK AVAILABLEUniquely-experienced Program LeaderResults-driven professional with broad experience driving complex projects to successful completion. Effective Project Manager of cross-functional teams in the development of medical devices, drug delivery systems, and drug therapies driven to succeed. Knowledgeable in timeline management, budgeting and resource management, as well as validation activities and pre-clinical/clinical study management. A certified Six Sigma Black Belt with a proven track record of technical and commercial achievement. Adept at developing novel concepts into workable solutions and driving them to successful commercialization. Author of numerous patents and publications.Project ManagementMedical DevicesCombination Drug DevicesPharmaceutical Drug DevelopmentValidation activitiesBudget managementCross-functional Core Team LeaderProject timelinesResource managementParexel, United States East Coast July 2023 - PresentSenior Global Biometrics Delivery Lead, Global Data OperationsAccountable for the execution of the Data Operations strategy and Data Operations technology setup for pharmaceutical clients. Manages database programming, data integration, clinical data management, and statistical services across programs.Drive adherence to contract dates by leading clinical study activities for pharma/biotech clients (Phase 1-3)Duchenne Muscular Dystrophy (DMD)Oncology (non-small cell lung cancer)Autoimmune Pulmonary Alveolar Proteinosis (aPAP)Ophthalmological conditionsManage relationships with Clients to ensure high satisfaction scores and continuity of businessLead improvements in overall profitability of studies by managing resource allocations for clinical studies, ensuring studies are executed as efficiently as possibleCurrently leading an internal initiative to improve timeline setup and execution - improving predictability and improving lead times for data management and biostatistics activitiesSirtex Medical, Woburn MA October 2022 July 2023Senior Program Manager Lead, M&A and Business IntegrationI joined Sirtex, based on a targeted recruitment by the company, to lead major initiatives related to business development and M&A activities. From day one, I adopted the responsibility of leading the Core Team in driving completion of the acquisition of a target company with advanced technology in the liquid embolic space, aimed at the treatment of embolism. As part of this initiative, I was responsible for ensuring the completion of all activities by both Sirtex and the target company, executing a smooth transition prior, during, and post-acquisition. This new business will drive significant double-digit revenue growth for Sirtex by 2024, while serving a market in need of novel therapies. This project, in addition to others, is in support of aggressive growth goals for the company.Contract Roles 2020 2022Network Partners, Warsaw, IN February 2022 October 2022Senior Program Manager Lead (Direct-hire Contractor)Responsible for program management of key accounts in the pharmaceutical and medical device spaces. Specifically, my skills & experience, as the Core Team lead, were used to manage project timelines, capital and expense budgets, resources, and project risk. Worked alongside Janssen Pharmaceuticals (subsidiary of J&J), where I managed pediatric clinical trials for the use of Simponi in treating ulcerative colitis, opening tens of millions in new revenue opportunity. In addition, I directed the closeout of several legacy projects eliminating millions spent on their support. Finally, I initiated several process improvement initiatives for the Janssen PMO Department, with the goal of transforming Janssen into a World-class project management organization.Biogen, Cambridge, MA February 2021 February 2022Senior Project Lead, Combination Medical Devices (Contractor)Directed project activities for the advanced Drug Delivery Platform, including Autoinjectors and on-body injectors used to treat Lupus, Alzheimers disease, Multiple Sclerosis, and other diseases. Managed large, global Core Teams from project scoping through clinical launch & sustained manufacturing, including budgeting, resourcing, timelines, risk management, process/product validations, and regulatory filings via FDA & ROW. This program supports billions of new revenues.Alexion Pharmaceuticals (acquired by AstraZeneca), New Haven CT March 2020 January 2021Operations Manager, Global Program Operations Management (Contractor)Managed multiple new product development and commercialization activities of combination device projects. Interacted with large, global partner companies to successfully bring to market new products for drug delivery targeting treatment of rare diseases. This included new applications for Ultomiris, the companys leading drug capturing $100s of millions in new product revenue. Additionally, I personally drove several Core Team initiatives, improving efficiencies within the PMO.Medtronic (Formerly Covidien), North Haven, CT 2009 - 2019Sr. Project Manager Office of Project Management Sept. 2012 - Jan. 2019Managed projects in the Hernia/Soft Tissue Repair/Hemostats and Mechanical Devices franchises. Successfully launched several new products, generating significant improved growth for the business. Responsibilities included: oversight of large, diverse Core Teams; management of project timelines/budgets/resourcing, as well as driving accountability of project teams and presenting project status to Executive-level stakeholders. Managed supply chain and demand forecasting with Logistics/Supplier management partners and key accounts suppliers. Experienced with QA/QE management, PPAPs, DFM, and all acceptance criteria. Please see selected projects below:Veriset Generated double-digit millions in new revenue in EU & ROW in a new Biosurgery space by leveraging proprietary technology. Project included driving the Core Team activities related to clinical trials in EU to prove safety & efficacy of the product, resulting in $10s of millions of new revenues.Spacemaker Pro Improved Medtronics Legacy product line to extend and expand offering in existing hernia mesh placement space, by leading the Core Team activities. The new product utilizes superior technology to improve the surgeons user experience & patient outcomes, driving >30% growth in the market segment and maintaining near-100% market share of the balloon-enabled hernia mesh access market.Velosorb Introduced a contract-manufactured suture product line to improve competitiveness in the soft tissue closure space. This new product line has helped maintain and drive double-digit growth of key accounts for the company.Sr. Project Engineer Advanced Manufacturing / Operations July 2009 Sept. 2012Drove successful completion of Core Team activities related to the commercialization of several novel suture and BioSurgery initiatives, including:V-Loc 180, V-Loc 90, & V-Loc PBT (multiple Phases) Developed/validated a manufacturing process to produce high-volume barbed-suture products a significant advancement in wound closure. This product line has produced well over $1 billion in new revenues for the company since its introduction.Veriset - Designed/optimized equipment and processes to produce a validated method for producing a revolutionary hemostat product for internal surgical procedures, driving ten of millions in new product revenue for the company.ATMI, Danbury, CT (Acquired by Entegris) 2000 2009Senior Research Engineer/Technologist & IP SopecialistAddressed aging, costly portfolio by assessing the value and business alignment of patent families and abandoning or offering for sale non-core or lower-value IP. Re-energized the creative engine of the company by creating and driving systems to encourage and develop high-potential ideas into new products.Realized savings of >$800k in first year (2008), representing a savings of over 25% of the overall patent budget.Partnered with Legal Team to create a new initiative within the company to strengthen relations with R&D/Operations.Greatly improved competitive knowledge of competitors using IP Alerts, eliminating millions spent on litigationUtilized Six Sigma methodologies to plan and execute new product development strategies to develop and launch successful, patent-protected products with high margin profiles.Other R&D highlights:Saved $500k by developing and implementing a process for reclaiming SDS GeF4 cylinders.Commercialized cluster molecules with partner SemEquip for plug & play solution in high-efficiency boron doping.Authored numerous patents and publications and leveraged IP knowledge to build higher-value patent protection.EDUCATIONBachelors of Science, Chemical Engineering, 3.7 GPA, University of New Haven, West Haven, CT, 2000American Institute of Chemical Engineers Student Award 1998/2000 & Senior Award - 2000RELEVANT SKILLSProject Management, Core Team Leadership, Capital & Expense Budgeting, Resource Management, Professional Executive Presentations, Process Validation, Equipment Validation, IQ / OQ / PQ execution, drug delivery devices (Autoinjectors and on-body delivery systems), ISO13485, ISO9001, Patent Engineering, IP landscaping, Mergers & Acquisitions, process automation & control, analytical monitoring/characterization techniques; Software: MS Project, MS SharePoint, MS Office Suite, MS TeamsCERTIFICATIONS / AWARDSMedtronic Inventor of the Year Award (2015), R&D Magazines R&D 100 Award (2008), Gassy Award recipient at Semicon West (2004), Six Sigma Black Belt, Safety Committee, Evacuation Team volunteerCandidate's Name
8 Manners AvenueSeymour, CT 06483PHONE NUMBER AVAILABLE EMAIL AVAILABLEhttps://LINKEDIN LINK AVAILABLEPATENT REFERENCESoMethod and Apparatus for the Abatement of Toxic Gas Components from a Semiconductor Manufacturing Process Effluent Stream, US Patent 7,364,603, Filed 8/27/2004, Issued 04/29/2008oFluid Storage and Dispensing Vessels Having Colorimetrically Verifiable Leak-tightness and Method of Making Same, US Patent 7,253,002, Filed 11/03/2003, Issued 7/07/2007oMethod and Apparatus for the Abatement of Toxic Gas Components from a Semiconductor Manufacturing Process Effluent Stream, US Patent 6,805,728, Filed 12/09/2002, Issued 10/19/2004oCleaning of Semiconductor Wafer and Flat Panel Display Processing or Fabrication Systems, ATMI- 904PRVoIon Source Cleaning in Semiconductor Processing Systems, ATMI-851, Q4/2007oComponent for Refrigeration System and Method of Making Such Component, ATMI-845, 06/2007oComponent for Refrigeration System and Method of Making Such Component, ATMI-843, 06/2007oCleaning of Semiconductor Processing Systems, ATMI-810, 03/2007oSystem for Delivery of Reagents from Solid Sources Thereof, US application PHONE NUMBER AVAILABLEoInfrared Gas Detection Systems and Methods, US application PHONE NUMBER AVAILABLEoApparatus and Method for Use of Indium Chloride to Deliver Indium Vapor to Ion Source, ATMI-786, 02/2006oHigh Conductance Valve for Use in Delivery of Low Pressure Fluids, ATMI-741, 03/2005oCIP for Method and Apparatus for the Abatement of Toxic Gas Components from a Semiconductor Manufacturing Process Effluent Stream, US Application PHONE NUMBER AVAILABLE, Filed 08/27/2004oGas-using Facility Including Portable Dry Scrubber System and/or Over-pressure Control Arrangement, US Application PHONE NUMBER AVAILABLE, Filed 10/24/2003oChemisorbent System for Abatement of Effluent Species, US Application PHONE NUMBER AVAILABLE, Filed 09/18/2003oColorimetric Gas Detector and Windowed Process Chamber, US Application PHONE NUMBER AVAILABLE, Filed 08/18/2003oLow Pressure Drop Canister for Fixed Bed Scrubber Applications and Method of Using Same, US Application PHONE NUMBER AVAILABLE, Filed 02/19/2003SELECTED PUBLICATIONSoIn-Situ Ion Source Cleaning: Review of Chemical Mechanisms and Evaluation Data at Production Fabs, Ion Implant Technologies Conference, June 2008oOptimization of Xenon Difluoride Vapor Delivery, Ion Implant Technologies Conference, June 2008oDevelopment of Static In-Situ Implanter Chamber Cleaning, Ion Implant Technologies Conference, June 2008oEmissions Monitoring and Exhaust Analysis for the Axcelis IMAX Molecular Ion Implanter, Ion Implant Technologies Conference, June 2008oA Vaporizer for Decaborane and Octadecaborane, Ion Implant Technologies Conference, June 2006oEnergy Cost Savings in Ion Implant: Development of an Air Recycle Unit, Ion Implant Technologies Conference, October 2004oRecent Developments in Gas Adsorption Technology for Effluent Treatment, Gases and Technology, July 2004oDevelopment of an Exhaust Air Recirculation Unit for Ion Implant Applications, SEMI Technical Symposium: Innovations in Semiconductor Manufacturing, June 2004oDevelopments in Abatement Technology for MOCVD Processing, Journal of Crystal Growth, June 2004oCharacterizing and Abating Ion Implant Process Effluents, MICRO Magazine, July 2003, pg. 73-80oDevelopment of Compact, Dry Abatement System for Multiple Process Applications, SEMI Technical Symposium: Innovations in Semiconductor Manufacturing, July 2003oGas-phase FT-IR Characterization of Ion Implant Process Effluents, Ion Implant Technology Conference, Sept. 2002oDevelopments in the Abatement of Ion Implant Process Effluents, Ion Implant Technology Conference, Sept. 2002oExhaust Reduction in a 300mm TEL Wet Station Using an Air Manager System, International Sematech, 2001 |
