ROBERT LEMON, MBA
A collaborative leader of people, projects and programs to help organizations to reach their product development goals rapidly and with full potential. Vast industry experiences leading product development, clinical supplies, new product launches, technology transfer, capital projects start to finish, end to end supply chain operations, technology transfer and commercialization of new assets.
• Leadership
• New Site Start-ups
• Capital Project Manager
• Technology Transfer
• Value Stream Mapping
• Regulatory Strategy
• Supply Chain Management
• Clinical Trial Supply
• LSS – Green Belt
• Program Communication
• Project Management - PMP
• Contracts & Supplier Mgmt.
EDUCATION
Master of Business Administration, Organizational Behavior & Leadership
•University of Phoenix, AZ 2002
Bachelor of Science, Biology & Environmental Science
•SUNY, Plattsburgh, NY 1998
PROFESSIONAL EXPERIENCE:
iCRYO Health & Wellness – Port St Lucie, FL
Program Manager 12/2023 - Current
New center construction, equipment procurement, Shipping & Logistics, vendor management, new store openings, forecasting supplies, and contract management. Lead of all activities to realize full P&L potential and maximize profit.
Consultant CMC Product Development – Project Manager 2023 – 2025
Manufacture clinical supplies, timeline management, communication w/stakeholders, analytical methods development and transfer, technology transfer, process changes, from site to site or lab scale up to commercial scale, LSS continuous improvement projects, value stream mapping.
Rational Vaccines - Consulting Position
Consultant - Project Director– Supply Chain Leader CMC, Clinical Supply 2020 - 2023
Primary focus on CMC, Technology Transfer, Supplies, Analytical Methods Capital Projects, Contracts with CDMOs. needed for clinical supplies, process changes and executing overall timeline for IND, P-1 and P-2 submission. Maintained overall timelines and alignment of broader organization to a single plan for the project.
IAVI, New York, NY 2016- 2020
Executive Director – Program Manager VxPDC (Vaccine Product Development Center)
Planning and development for portfolio of projects require resources to develop and commercialize new products. Scale up and tech transfer, capex project management and supply chain management. IAVI acted as virtual CDMO w/ multiple partners.
Merck, West Point, Pa 2010-2016
Project Director and Operations Leader – Technical Operations & Supply Chain Management Provide Leadership and project management for end-to-end supply chain and lifecycle management of key products in Merck manufacturing Vaccines division. Led multiple process improvement and capital projects to build out for Vaccines and Biological manufacturing processes. Leader for Technology transfer for Phase 3 to commercial global supply chain end to end management. Owner for capital projects in portfolio.
Pfizer, Collegeville, Pa 2009-2010
Sr. Project Leader, Global Mfg. Services
Provide leadership end to end supply chain activities, order management, prioritization, and manage resources for leadership of new product launches, supply chain development and management, clinical supplies, new site/capacity start-ups, tech transfer, business development deals, key lifecycle enhancement projects and other company objectives. Leadership of Capital Projects, Pipeline integration & Technology transfer teams.
Wyeth, Collegeville, Pa 1992-2009
Strategic Product Leader – Supply Chain
End to end Supply Chain Leader for Major Brands within supply chain. Managed capacity and process changes required to maintain capacity and cost of goods targets. Premarin, Enbrel, Effexor XR,
Leader of Team of Project Leaders that managed Global Technology Teams for clinical supply in tandem w/ Pharmaceutical Sciences and Manufacturing Operations as a portfolio of assets for the company’s future growth. Provide and manage Clinical trial supplies for new product development and communication of plans to achieve. Managed Tech Transfer Oversight Committee and Process. Alliance manager for Immunex partnership for the development, scale up and commercialization of Enbrel. Leader for multiple capital project to expand capacity and revenue.
Business Process Consultant/Project Manager– Global Forecasting Transformation Project. Selected by CEO to Lead Forecasting Transformation team and provide strong subject matter expertise in support of key transformation initiatives. Established exceptional results delivering short / long term product forecasting & planning processes to enhance supply chain operations. Became forecasting and risk management expert.
Global Project Manager – Global Supply Chain
Alliance manager with Immunex in Support of Enbrel partnership. Launched and managed Enbrel Lifecycle 1st 5 years on the market. Owner for Capital project in portfolio. Communicated with and aligned strategy for multiple capital projects, process, analytical changes, site changes and regulatory approvals to meet massive market demand and stakeholder expectations. Owner/Leader for Capital Projects for Enbrel Capacity Expansions.
Sr. Project Manager – Pharmaceutical Development Operations
Support US market for new product launches and transition to global market. Technology transfer operations and execution.
Master Planner– Production Control Plant Manufacturing Rouses Pt., NY
Focus Factory Manager, Buyer/Planner, Material Scheduler, Production Supervisor.
PROFESSIONAL DEVELOPMENT
•JMT John Maxwell Team - Certification in Leadership, Coaching & Speaking 3/17.
•KJCG: Kaleel Jamison Consulting Group. CICP; Core Inclusion & Change Partner 12/16
•Villanova University: Leadership & Organization Behavior in the 21st Century 12/16
•Villanova University: Lean Six Sigma Methods Green Belt 12/15
•PMP PMBOK PMP Certificate for Professional Project Managers 12/12
•AMA: Risk Analysis, Project Management, Business Writing 10/12
•APICS: Inventory Management / Master Scheduling 6/07
•Villanova New Drug Development Courses, pre-IND to Commercial – 12/11
•Industry Standards, Stability & Shelf Life. 12/18
•Rosenblatt & Klauber; Group Product Forecasting, 12/09
•Expert courses in Risk Management & Mitigation. 9/10