Program Management for Monoclonal Antibody Process Development and Manufacturing: Phase 1 through BLA


October 19, 2010
11:30 – 1:00 pm EST

 

Course Description 
Many scientists and engineers find themselves in Project Management roles as they progress through their careers. Whether you are a recent graduate or a seasoned professional, Project Management skills are imperative to successfully executing complex, multi-year development programs. This course is designed to assist scientists and engineers make the transition from technical management to project management and learn how to apply the skills of a professional project manager to complex monoclonal antibody development programs.

Learning Objectives

  • The fundamentals of Project Management that can be applied to most pharmaceutical development projects, including Work Breakdown Structures
  • Strategic and tactic decision making that impacts Project Management
  • Operational planning:
  • Project Planning: aggregate timelines, milestones, critical path
  • Resource Planning: resource forecasting, FTE plans. Budgets
  • Resource Management: resource allocation, optimal resource utilization
  • Reporting: resource usage, actual: to: plan reporting, timeline reporting
  • Performance Measurement: key performance indicators, benchmarking
  • Project Teams and Leadership Competencies
  • Effectiveness Competencies
  • Leadership Competencies
  • Collaboration Competencies
  • Knowledge Competencies
  • Specific examples of project management issues applied to monoclonal antibody development and manufacturing

 

Who Should Attend: 
Project / Program Managers / Leaders
Process/Method Development Leaders (Manager, Director)
Manufacturing Leaders (Manager, Director)

About the Instructor: 
Patricia Seymour, M.B.A., Senior Consultant, BioProcess Technology Consultants, Inc.
Patricia Seymour has over 20 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development and manufacturing, supply chain strategy and management and operations leadership. Her current activities include: developing overall CMC strategies for diverse product pipelines, developing and implementing outsourcing strategies, managing outsourced process development and manufacturing activities from drug substances through to distribution, steering clients through CMC regulatory requirements and overall CMC operations including project management and budgeting. Prior to joining BioProcess Technology Consultants, Ms. Seymour was Senior Director, Global Investigational Supply Operations at Millennium Pharmaceuticals, Inc., where she worked with other senior leaders to develop and implement CMC strategies including outsourcing. She was previously Director of Business Development at Covance Biotechnology Services (now Diosynth) where her responsibilities included negotiating contact manufacturing projects. As Senior Director, Corporate Development at Collaborative BioAlliance she was instrumental in launching the new contract manufacturing business unit. Before Collaborative, Ms. Seymour held research and development positions at ImmunoGen, Dana Farber and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University. Ms. Seymour is Certified Supply Chain Professional (APICS).


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