Kay Schmidt

Kay Schmidt Email and Phone Number

Executive Cross Functional Leader | Pharmaceuticals | Medical Devices | R&D | Operations | Mission Critical Technical Solutions @ Exact Sciences
Madison, WI
Kay Schmidt's Location
Milwaukee, Wisconsin, United States, United States
Kay Schmidt's Contact Details

Kay Schmidt work email

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About Kay Schmidt

As a demonstrated technical and people leader in the Medical Devices and Pharmaceuticals industry, I am passionate about driving innovation and delivering mission-critical technical solutions. With a strong background in Remediation, R&D, Operations, Engineering, and Portfolio/Product/Project Management, I bring a unique blend of skills and expertise to the table. My guiding principle is to continuously improve processes and drive process improvement initiatives that have a direct impact on business performance. With extensive experience in leading cross-functional teams and delivering successful outcomes, I have developed a deep understanding of the complexities of the industry. My areas of expertise include developing extensive playbooks, ensuring preparedness ensuring efficiency and optimization, and monitoring performance through digital dashboards. I have also excelled in leading product development and project management teams, delivering numerous new product introductions across multiple dosage forms. Additionally, I have successfully managed central teams in EHS&S, Supply Chain, Procurement, Risk Management, and Security, driving operational excellence and achieving key performance indicators.Throughout my career, I have achieved significant milestones and received recognition for my contributions I spearheaded the establishment of sustainability targets, resulting in a significant increase in the use of renewable energy sources and landfill diversion. Furthermore, I have successfully implemented Lean initiatives, improved central training platforms, and transformed business analytics reporting.My goal is to leverage my skills and expertise to make a difference for organizations and their stakeholders. I am committed to driving business growth through innovation, improving operational efficiency, and fostering a culture of continuous improvement. I thrive in challenging environments and am always seeking new opportunities to drive positive change. I look forward to connecting with like-minded professionals and exploring how we can collaborate to achieve our goals and ambitions.

Kay Schmidt's Current Company Details
Exact Sciences

Exact Sciences

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Executive Cross Functional Leader | Pharmaceuticals | Medical Devices | R&D | Operations | Mission Critical Technical Solutions
Madison, WI
Employees:
501
Kay Schmidt Work Experience Details
  • Exact Sciences
    Vp Operations Transformation
    Exact Sciences Apr 2024 - Present
    Madison, Wisconsin, Us
  • Catalent Pharma Solutions
    Senior Vice President, Enterprise Functions
    Catalent Pharma Solutions 2019 - 2023
    Somerset, Nj, Us
    • Functional excellence of companywide, customer-facing Product Development and Project Management teams. Delivered 200+ new product introductions/year of multiple dosage forms.• Central EHS&S team, with notable accomplishments of recordable injury rate <0.5 in for diverse pharmaceutical manufacturing operations. Established and sustainability targets from 2019 through 2030 with targets electricity, water and waste. 2023 delivered 81% of electricity from renewable sources, up 252% from prior year and 65% landfill free. • Central Supply Chain team, delivering without shortages disruption throughout the pandemic, finite and long term planning tool kits improved and trained across the enterprise, also supported multiple ERP deployments.• Central, then Global Procurement team. Met or exceeded all cost productivity targets (approximately FY $100M savings), reorganized first leadership then procurement professionals to enable cost, quality and delivery target attainment. Improved time supplier payments by 30% across the network.• Central Enterprise Risk Management (ERM) and Security. Developed ERM function, incorporating enterprise-wide Insurance and Controlled Drug Substance responsibility and revamped Security policies and procedures.• Global Project Management Office. Led select group of Project Managers to address critical business objectives, projects and remediation efforts .• Global Organizational Leadership Development program. Budget owner and functional leader for entry level talent development program. Grew and scaled program over 100% to address companywide talent needs.• Continuous Improvement, Training, and Business Analytics; developed content and kicked off Lean initiative, extensively improved central training digital training platform and tied it to HR systems for optimization, and transformed business analytics reporting through standardization and digital platform change.
  • Catalent Pharma Solutions
    Vice President, Product Development For Biologic Products | Vp, R&D For Sterile And Oral Products
    Catalent Pharma Solutions 2013 - 2019
    Somerset, Nj, Us
    Led product development teams, overseeing entry points from phase 1 development to clinical to scale up through commercialization, including analytical, formulation, and process development for multiple oral, specialty, sterile and biologic dosage forms. Directed customer-facing project management teams handling internal, cross-functional execution and revenue recognition. • Served as technical leader for complex, modified release generic approved by FDA. • Led conversion to ASC 606 accounting processes for project revenue. Standardized practices across the network to ensure internal and customer satisfaction and compliance. • Provided technical and execution oversight of entire portfolio with over 1000 active projects. Led operating reviews to meet KPIs: project health, customer temperature and on time delivery.
  • Catalent Pharma Solutions
    Director Of New Product Development, Sterile Products
    Catalent Pharma Solutions 2009 - 2013
    Somerset, Nj, Us
    Directed product development, engineering and project management team for Blow, Fill, and Seal and prefilled syringe dosage forms. • Developed and introduced first stage gate development process, branded NPIx (New Product Introduction eXcellence), subsequently operationalized and adopted company-wide in global functional and quality systems. • Improved customer satisfaction and revenue growth year over year throughout tenure.
  • Ge Healthcare
    Director Of Engineering And Operations, Bone Mineral Densitometry
    Ge Healthcare 2008 - 2009
    Chicago, Us
    Provided leadership and direction for Engineering and Operations. • Oversaw cost, quality and delivery from MSN, WI and Wuxi, China operations. • New product program technology execution and roadmap owner for ultrasound and x-ray-based bone mineral density and metabolic health devices.
  • Ge Healthcare
    Center Of Excellence Manager, X-Ray Detectors
    Ge Healthcare 2005 - 2008
    Chicago, Us
    Directed over 60 engineers overseeing X-ray Detectors for Vascular, Mammography and Radiography systems. • Increased production >50% at 2 manufacturing locations, 1 internal and 1 contract manufacturer. • Secured over $160M plant and equipment investments.• Grew low-cost country manufacturing and engineering organizations to provide faster, lower-cost new products.
  • Ge Healthcare
    Program Manager, X-Ray Tube For Ct
    Ge Healthcare 2003 - 2005
    Chicago, Us
    Brought in to manage new product introduction in crisis, overseeing activities of 40+ engineers. • Ramped production >100% and increased product life 6x in 3 months. • Reviewed and wrote numerous quality investigations to resolve and prevent defects.
  • Ge Healthcare
    Manager Service Operations And Productivity, Functional Imaging Service
    Ge Healthcare 2000 - 2003
    Chicago, Us
    Led team of 4 ops managers and 30 zone engineers to improve capacity, competency and customer satisfaction for Nuc Medicine, Cyclotron and PET customers.• Improved customer rating from #3 to #1 in one year. Received highest industry ratings for field engineer competence.• Delivered approximately $40M of cost productivity, plus $12M growth revenue. Revenue up 8%, margin up 16%.• Led remote support center, directing 80 engineers supporting customers and field engineers across 8 diagnostic imaging modalities. Reduced costs $2M/yr with transition of call handling to India.
  • Ge Healthcare
    Various Technical Roles
    Ge Healthcare 1983 - 2000
    Chicago, Us
    Manager CT Detector Operations | 1998 to 2000X-Ray Tubes, Business Team Leader, Program Manager | 1994 to 1998Nuclear Medicine Technical Transition Leader | 1993 to 1994CT Quality Programs, Shop Operations, New Products Manager | 1988 to 1993CT Software Engineer/Software Project Leader | 1983 to 1988

Kay Schmidt Skills

R&d Cross Functional Team Leadership Medical Devices Product Development Six Sigma Program Management Gmp Quality System Leadership Medical Imaging Pharmaceutical Industry Engineering Biotechnology Iso 13485 Design Of Experiments Process Simulation

Kay Schmidt Education Details

  • Carroll University
    Carroll University
    Computer Science
  • University Of Wisconsin-Whitewater
    University Of Wisconsin-Whitewater
    Industrial Safety

Frequently Asked Questions about Kay Schmidt

What company does Kay Schmidt work for?

Kay Schmidt works for Exact Sciences

What is Kay Schmidt's role at the current company?

Kay Schmidt's current role is Executive Cross Functional Leader | Pharmaceuticals | Medical Devices | R&D | Operations | Mission Critical Technical Solutions.

What is Kay Schmidt's email address?

Kay Schmidt's email address is ka****@****hoo.com

What is Kay Schmidt's direct phone number?

Kay Schmidt's direct phone number is +181533*****

What schools did Kay Schmidt attend?

Kay Schmidt attended Carroll University, University Of Wisconsin-Whitewater.

What skills is Kay Schmidt known for?

Kay Schmidt has skills like R&d, Cross Functional Team Leadership, Medical Devices, Product Development, Six Sigma, Program Management, Gmp, Quality System, Leadership, Medical Imaging, Pharmaceutical Industry, Engineering.

Who are Kay Schmidt's colleagues?

Kay Schmidt's colleagues are Ryan O'neil, Paris Chávez, Ryan Sweeney, Bryan Heckman, Liliana Mckinnis, Edmond C., Adam Maida.

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