Micah Okeefe

About Micah Okeefe

Senior Pharmaceutical Leader with demonstrated success leading technical operations, managing internal & external (contract) manufacturing organizations (CMOs). I create vision and strategy, hire/grow teams, and manage technical operations functions, delivering new product launches, manufacturing process transfers, life cycle management projects, as well as cost, quality, and remediation improvement results. Outstanding communicator with ability to share vision and gain internal and third-party agreement. Turnaround leader with an established reputation for leading and completing complex projects to include building and growing a $13B External Supply Operations (ESO) dept for the Americas region and leading a multi-billion tech transfer, from internal production sites to CMOs, for a diverse drug product manufacturing portfolio. Develops trusted relationships with internal executives and third-party stakeholders. Conducts due diligence on potential suppliers and manages relationships throughout outsourced agreement lifecycles. Senior management values my ability to take charge of critical company initiatives, including department operationalization, FDA 483 remediations, quality improvements, and cost-improvement projects.Successes include: KEY OUTSOURCED PRODUCTS: Facilitate on time, full delivery of key outsourced products with annual sales up to $13B. TURNAROUND LEADER: Established reputation for taking charge of and delivering challenging projects. CRITICAL PROGRAM VISION, STRATEGY & DELIVERY: Took charge of stalled department launch to successfully form team, driving Tech Transfers of drug product manufacturing & packaging to external suppliers. NEW PRODUCT LAUNCH: Successfully managed numerous new product launches at internal & external sites. TEAM GROWTH & LEADERSHIP: Drove team integration & expansion, hiring, training, & managing new associates. Led cross-functional project teams across Project Management, Quality, Supply Chain Management, Procurement, Engineering, MS & T, Validation, Regulatory, and Change Management functions. PROGRAM & PORTFOLIO MANAGEMENT: Led 3-year $11B Tech Transfer of drug product manufacturing & packaging portfolio to USA CMOs. QUALITY INVESTIGATION | LOSS AVOIDANCE: Led investigation identifying root cause and preventing estimated $17M product loss. FDA 483 OBSERVATIONS REMEDIATION: Drove remediation of major FDA 483 observations, meeting critical timeline FDA commitments. CAPITAL PROJECTS: Delivered site-critical production line, significantly reducing average cost/pack metric.

Experience

1. Program Lead

   辉瑞

   Jan 2025 — Present · US

   Providing consulting services to Pfizer and IBM Consulting through O\'Keefe Professional Consulting Services, LLC.Managing design, development, testing, integration, and deployment of digital software solution projects for the global Pfizer External Supply organization.Responsible for on-time delivery of software solutions, Team leadership, management of project plans and timeline, stakeholder management, and end user / customer engagement & feedback.Duties include planning, organizing and directing projects within the program to completion, on-time and within budget. This includes resource management, assigning tasks, delegating responsibilities, monitoring progress, change management, leading meetings, team motivation, and communication. Develop roadmaps with timelines, resources, and tasks.Identify and manage risks within the program.Lead CMO engagement related to the program goals.Partner with Solution Design, User Experience and Solution Adoption teams to design, develop, and implement optimal solutions for efficiency and which enhance the user experience.Responsible to meet financial savings goals of the program.

Education

• Seton Hall University School of Law

  Doctor of Law - JD

• Michigan State University

  Bachelor of Science