Program Manager Health Care

Scott Sackinger, PHD, PMP

Kirkland, WA ***** 503-***-**** **************@*****.*** http://www.linkedin.com/in/scottsackinger Sr Program Manager

Medical Device,Pharma and Wound Care Project /Program Manager responsible for cross-functional team leadership from concept development to commercial launchofregulatedproducts.Programmanagedearly& late-stage pharma development of ADC cancer therapies.Delivered Oral Health Care Devices,Regulatory EU MDRcomplianceandNPIprojects.Obtained510Kclearanceandfacilitystart-upcompliantwith21cfr820.Led ateamof20engineersinthevalidationandintroductionofnewmedicalproducts.Managedapharmaportfolio using Planisware to support drug development teams. Core competencies

Project / Program Management Oncology Research Development Governance Planning Risk Assessment Technical contribution areas: trauma wound care, thermoplastic extrusion, gel extrusion, composite materials, continuous filament and bi-component spinning, nano-scale polymer filaments and non-woven technologies. Professional Experience

PFIZER (via SEAGEN merger)2024 - 2025

$63 billion multinational pharmaceutical and biotechnology company. Associate Director, Asset Program Manager

PRD PMSO Program Management – Oncology Research Development.Supported early-stage cross functional drug development teams with planning and schedule management using Planisware.

● Built new plans which achieved governance approval based on proposed clinical schemas. SEAGEN 2022 - 2024

$2 billion global biotechnology company developing revolutionary cancer therapies acquired by Pfizer in late 2023. Sr Program Manager

PlannedandfacilitatedactionstowardkeyprogramprioritiesinpartnershipwithGPM,GPT,programleaderand functional leads.Developed agendas,facilitated meetings,recorded minutes,led/contributeddocuments,and supported governance preparation including Executive Leadership team and Board of Director presentations.

● Led/contributed to ongoing program risk assessments and program reporting as well as governance planning.

● Supported late-stage development objectives for PADCEV,a treatment for Urothelial Cancer by the coordination of cross function teams achieving governance which led to protocol approvals and applications.

● Organized GPT goal setting for PADCEV.Provided task and timeline management for the PADCEV CDx Biomarker working group (x-function w/partner.

Philips Oral Health Care 2013 - 2022

Consumer Life - $1 billion division offering oral health care products including Sonicare and Philips Zoom. Program / Project Manager

Integratedandcross-functionalProject/ProgramManagerforthedevelopmentandNPIofconsumeranddental professional whiteningproducts.PortfolioManagementforaPhilipsOralHealthCareBusinessUnit-Sustaining and Operations. EU MDR Program Manager responsible for compliance for Philips Oral Health Care.

• Post-Merger Integration Operations Program /Project Manager for Oral Health Care-cross-functionalPM defining future statue of a previous Philips acquisition: completed for deployment preparation for IT system. Scott Sackinger **************@*****.*** Page 2

• LCMProjectManagerforWhiteningincludingcommercial,technicalprojectsincrementalandintroductions to new countries- for example, Brazil and China.

• ManagedR&DProgramforcrossfunctionandmulti-site/multi-nationalearlydevelopmentandtechnology proof of concept for a Retail Whitening device. $5 million annual budget with a team of 30 professionals.

• Led the integrated Project,technical development,process development and product commercialization resulting in the the global launch of Philips Zoom QuickPro- an innovative in-office whitening treatment.

• InitiatedBothellsitestudycoursetoenableprofessionalstoprepareforProjectManagementInstitutePMP certification with nearly 100% success rate.

TE Connectivity- (previously Tyco Electronics)2011 - 2012 Medical Products Division -$265M division of custom electro-mechanical interconnect devices for Medical Device industry.

Manufacturing Engineering- (Manager NPI)

Managedagroupof20NewProductIntroductionEngineersresponsiblefortheprocessdevelopment,validation and commercialization of the new wire and cable interconnect sub-assemblies used for medical devices.

• Brought structure to the NPI process by leading implementation of a proceduralsystemfordevelopment objectives aligned with the stage gated development process, resulting in increased engineering efficiency.

• Led the introduction and training of new process validation systems for the Manufacturing Engineers. Oregon Biomedical Engineering Institute (OBEI)2009 - 2011 Develops andcommercializesmedicaltechnologyfocusedonnewbiomaterialsandwoundcarefortreatingtraumatic injury.

Consultant: Process Engineering / Project Manager

Led process development,product improvement and developed the manufacturing and validation plan for a medical device used in the treatment of life threatening non-compressible hemorrhage.

• Translated a laboratory concept into a commercially viable product and process with cost reductions.

• Led pilot scale prototype production for pre-clinical trials.

• Participated and contributed to pre-clinical trial protocols while working closely with the surgical team.

• Led development efforts for the sterilization protocol for the new product.

• Developed the manufacturing plan for a facility to produce the device.

• Specified process equipment and wrote the validation plan for installation and qualification. ENTEK Manufacturing / Ore-Medix 2004 - 2008

ENTEKManufacturingprovidesspecializedextrusionsystemsanddevelopsnewmaterialsforwoundcareandotherhigh value applications. Ore-Medix, a start-up subsidiary, is a medical device company. Product Development Manager

Ledtheapplicationscouting,discovery,productdevelopment,pre-clinicalefficacytrialsandcommercializationof a novel wound care dressing used in the treatment of traumatic and life-threatening hemorrhage.

• Invented,developedandcommercializedTRAUMASTAT™-arapidhemostaticdressingbasedonchitosanand a porous nano-fibril network of highly loaded fibers forming a non-woven dressing- life saving results.

• Presented concept and pre-clinical trial data to the US Army Institute of Surgical Research.

• Oversaw clinical development and pre-clinical trialsresultingintwopublications:JournalofTrauma-Injury Infection &Critical Care.65(4):884-892,October 2008 and North Pacific Surgical Association November 2008.

• Obtained FDA 510K clearance and implemented of the Quality Management System. LP Corporation (formerly Louisiana-Pacific)

Building products manufacturer of Oriented Strand Board (OSB) and specialty products. Scott Sackinger **************@*****.*** Page 3

Manager. Technology and Quality

LedtechnologydevelopmentandQualityinitiativesformultipleplantsmanufacturingawoodfilledhighdensity polyethylenecomposite.Directedplantengineersforprocessimprovementsandcostreductions.Oversawcode certification and managed the warranty and claims aspect of the business.

• Proposedandimplementedthetechnologyforentrystrategy,andforcommercializationofWeatherbest™, LP’s composite decking business.

• Led R&D for the new business, with multi-site responsibility for Quality and Manufacturing technology.

• Improvedproductattributesandqualitybasedonmarketfeedbackwhileimplementinga$2million/year cost reduction.These improvements led to “New Product of the Year” rating by an industry trade publication.

Venture Manager

Startupandgeneralmanagementforajointventureandnewproductintroduction.Builtapolymerproduction facility,hiredplantandsalesstaff.P&LresponsibilityforLP-PolymersLLC,subsidiaryofLPCorp.Commercialized FlexSeal™- an extruded thermo-formable polymer-wood composite substrate for automotive interior trim. DuPont Company

DuPont Nylon: Multi-national manufacturer of continuous filament Nylon. Sr. Research Engineer

Led technical effortsfornewproductdevelopmentandprocessimprovementwhileparticipatingonMarketing teams to define trends and define new product concepts. Led scale-up of newly developed processes.

• Managed a development semi-works for a 300 million pound per year Nylon fiber production facility. Provided technical leadership for new products, process development and process optimization.

• Developed aNylonspinningprocessoptimizationmethodthatreducedproductdevelopmenttimeby70% and increased yield 1% on 300 million pounds of annual nylon fiber production.

• Led a cross functional team (sales,marketing,operations and technical)which conducted customer interviews and developed a new fiber offering with a five-year NPV of $10 million. Education

Ph D-Chemical and Polymer Engineering,Universityof Massachusetts Thesis Title: The Determination of Swelling Stresses in Thin Polyimide Films BCHE, University of Delaware

Professional Recognition

• BestSmallBusiness-Region12inMichiganforstartingLPPolymers,asubsidiaryofLouisiana-Pacific,with recognition from Governor Engler and US Senator Abrahams.

• Gold Technology and Quality Award -Louisiana-Pacific Corporation.Awarded by the CEO and VP of Technology for demonstration of resourcefulness during a plant/ business start-up.

• Special Compensation Award by DuPont for discovering &eliminating $1 million/yr in-process material losses.

Patents

• Conformable Structured Therapeutic Dressing WO08036225A3.

• Surface-Coated Particulate Additives for Polymers US05643592. Scott Sackinger **************@*****.*** Page 2

• Polymers with Electrical and Non-linear Optical Properties US05604292.

• Process for Making Amino Functional Polypara-Phenylene Vinylene(s) US05578699.

• Improve Fade and Scratch Resistance for Wood Filled Thermoplastics Composites.

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