Jason Stephens

About Jason Stephens

My history of success is directly related to my ability to manage multimillion-dollar project operations and top-performing teams. I have demonstrated success in program and general management, IT implementations, project execution, process improvement, business analysis, and executive planning complemented by a broad understanding of the biopharmaceuticals and medical device industries. I am an adaptable and transformational leader who possesses acute business acumen and expertise in implementing distinctive operational strategies to attain breakthrough corporate objectives in fast-paced environment. Others have described me as a motivated individual with excellent communication, negotiations, problem solving, and people management skills.

Experience

1. Associate Director, Project and CMO Management

   Lundbeck

   Dec 2022 — Present · Bothell, WA, US

   Collaborates with cross-functional leaders, both within Lundbeck and Contract Manufacturing partners, to guide the development and implementation of new biologics products from development, clinicals to commercialization. • Provide project and Contract Manufacturing Organization (CMO) management expertise for the delivery of key initiatives. • Establish and manage project development and execution through across the CMC organization and with Lundbeck CMO partners, ensuring expected timelines and milestones are achieved.• Lead and collaborate with internal and external cross-functional teams including Manufacturing, Process Development, Analytical and Formulation Development, Quality Assurance, Quality Control, Validation and Regulatory. • Proactively identify and communicate obstacles, risks, or critical issues to development plans; develop and implement appropriate mitigation strategies with key stakeholders within CMC Biologics management. • Support and contribute to defining project management best practices and tools within the Lundbeck PMO/CMO organization.

Education

• University of Denver - Daniels College of Business

  MBA

  2008 — 2010

• Abilene Christian University

  BS, Biochemistry and Molecular Biology

  1998 — 2002

Skills

• Microsoft Office
• Conflict Resolution
• Project Server
• Product Management
• Market Research
• Due Diligence
• Business Analysis
• Corporate Development
• Business Process Improvement
• Orthopedics
• Fda
• Project Management
• Malcolm Baldrige
• Management
• Orthopedic
• Process Improvement
• Non-Profits
• Microsoft Office Sharepoint Server
• Competitive Analysis
• Stem Cell Technology
• Strategic Planning
• Financial Modeling
• Medical Devices
• Forecasting
• U.s. Food and Drug Administration (Fda)
• Microsoft Excel
• Product Development
• Technology Transfer
• Program Management
• Biologics
• Financial Analysis
• Legal Structures
• Sharepoint
• Iso 13485
• Leadership
• Pmo Development
• Cross-Functional Team Leadership