Marian Phelan
Charlottesville,USA
Summary
Global pharmaceutical manufacturing executive with 20+ years of progressive leadership across biologics, vaccines, sterile fill-finish and solid-dose manufacturing in highly regulated cGMP environments. Proven track record leading large-scale manufacturing organizations, driving operational transformation, and delivering reliable commercial supply for critical medicines. Experienced operations leader with P&L accountability, responsible for multi-hundred-person manufacturing organizations and complex supply networks. Recognized for delivering significant capacity expansion, operational excellence, and regulatory compliance while improving cost performance and manufacturing efficiency. Passionate about safety of our team and our patients. Deep expertise in process scale-up, technology transfer, commercialization, and manufacturing network strategy, with a strong track record working with global pharmaceutical leadership and external partners. A collaborative and people-focused leader known for building high-performing teams, developing future leaders, and driving a culture of safety, quality and continuous improvement.
Overview
30
30
years of professional experience
Work History
Executive Director, Operations – ExM Vaccines Strategy and Supply Lead
Merck & Co Inc
01.2025 - Current
- Defined strategic operating model for vaccine external manufacturing, enhancing global supply continuity and enabling long-term portfolio growth.
- Established mission and governance model for external manufacturing, designing end-to-end supply chain processes that improved demand alignment, risk management, and commercial supply reliability.
- Partner with senior leadership to prioritize capital investments, supply strategies and technology partnerships supporting global vaccine programs.
- Developed performance management framework with KPIs and supply reliability metrics, creating operational dashboards to enhance visibility and decision-making.
- Sponsor for digital manufacturing enablement initiatives improving network visibility and decision-making.
Executive Director, Operations – HPV Vaccines Operations
Merck & Co Inc
Elkton, USA
08.2022 - 12.2024
- Led large-scale vaccine manufacturing operations, aligning site execution with global product strategy to enhance operational effectiveness.
- Developed and implemented multi-year manufacturing strategy across three production trains supporting global HPV vaccine supply.
- Contributed to global supply planning, launch readiness, and CMC strategy as a member of the Global HPV Value Chain Management Team.
- Led cross-functional programs for technology transfer, validation and regulatory readiness supporting global commercial supply.
- Directed significant operational changes, ensuring safety, quality, and supply continuity during transitions.
Director, Operations – HPV Vaccines Operations
Merck & Co Inc
Elkton, USA
05.2018 - 08.2022
- Operations leader accountable for end-to-end vaccine manufacturing across fermentation, purification, adjuvant, aseptic preparation and materials operations.
- Delivered >200% increase in production capacity through operational transformation, process optimization and workforce engagement.
- Oversaw safety, compliance, production output, operational performance, and budget management to ensure operational excellence.
- Led a 275-person manufacturing and maintenance organization in a unionized environment.
- Strengthened inspection readiness and regulatory compliance, enhancing manufacturing reliability and productivity.
Director, Supply Chain Management (SCM) – SCM Site Lead
MSD Ireland
Carlow, Ireland
01.2014 - 05.2018
- Senior leadership team member managing integrated supply chain operations for a high-volume pharmaceutical manufacturing site.
- Coordinated global supply chain activities across Europe, United States, and Asia, ensuring alignment and responsiveness to market needs.
- Led demand planning, procurement, logistics, inventory management, and product distribution to streamline operations and enhance service delivery.
- Oversaw supplier relationships, change management, and regulatory compliance to maintain supply network integrity and mitigate risks.
- Implemented integrated MES/SAP systems to improve production planning and quality synchronization.
Associate Director, Engineering - EPM (Enterprise Process Management)
MSD Ireland
Carlow, Ireland
08.2011 - 01.2014
- Directed SAP sustainment and continuous improvement efforts at Carlow manufacturing site to optimize performance.
- Led enterprise systems and digital manufacturing initiatives to enhance operational capabilities.
- Led MES strategy and vendor validation activities including CSV, IQ/OQ/PQ.
- Oversaw supplier material specifications and change control processes to ensure compliance and quality standards.
Process Engineer - MES & SAP Deployment Lead
MSD Ireland
Carlow, Ireland
05.2009 - 08.2011
- Led SAP deployment and digitalization initiatives, streamlining manufacturing processes and improving data accessibility.
- Implemented electronic batch record (EBR) systems, enhancing accuracy and compliance in manufacturing operations.
- Introduced innovative component traceability systems, increasing compliance and enhancing operational transparency.
Site Lead for MES Deployment
Wyeth Pharmaceuticals
Newbridge, Ireland
08.2005 - 05.2009
- Developed an electronic batch record (EBR) fully integrated with the Automation/SCADA system while deploying the MES system in association with a major start-up facility.
- Managed daily site operations for pharmaceutical manufacturing and distribution.
- Oversaw compliance with safety regulations and quality standards in production.
- Coordinated cross-functional teams to enhance communication and workflow efficiency.
Compliance Specialist
Wyeth Pharmaceuticals
, Ireland
11.2003 - 08.2005
- Directed quality compliance and process improvement programs for the Factory Director.
- Ensured compliance with regulations and internal policies for pharmaceutical products.
- Conducted audits to identify compliance gaps and recommend corrective actions.
- Collaborated with cross-functional teams to develop compliance training programs.
Manufacturing Supervisor
Wyeth Pharmaceuticals
, Ireland
07.1999 - 11.2003
- Directed front-line operators in solid-dose pharmaceutical manufacturing within a unionized setting.
Lab Analyst / Development Manager
Independent Analytical Services Ltd.
Bagenalstown, Ireland
10.1995 - 07.1999
- Performed microbiological and analytical testing to ensure compliance for environmental and food industry clients.
Education
Batchelor of Science - Microbiology (Hons)
University College Cork
Ireland01-1995
Skills
- Site & Plant Leadership
- P&L Ownership & Financial Performance
- Operational Excellence (Lean / Six Sigma)
- Manufacturing Strategy & Capacity Expansion
- Technology Transfer & Commercialization
- Regulatory Compliance (cGMP / FDA / EMA)
- Supply Chain & Global Network Operations
- Talent Development & Organizational Design
- Capital Investment & Facility Expansion
- Cross-functional Leadership & Stakeholder Alignment
- CDMO governance
- Biologics & Vaccine Manufacturing
- Fermentation & Upstream Processing
- Downstream Purification & Chromatography
- Aseptic fill-finish
- Solid dose manufacturing
- Process scale-up
- Greenfield Facility Design & Startup
- Commissioning validation
- MES / SAP / Digital Manufacturing System
Timeline
Executive Director, Operations – ExM Vaccines Strategy and Supply Lead
Merck & Co Inc
01.2025 - Current
Executive Director, Operations – HPV Vaccines Operations
Merck & Co Inc
08.2022 - 12.2024
Director, Operations – HPV Vaccines Operations
Merck & Co Inc
05.2018 - 08.2022
Director, Supply Chain Management (SCM) – SCM Site Lead
MSD Ireland
01.2014 - 05.2018
Associate Director, Engineering - EPM (Enterprise Process Management)
MSD Ireland
08.2011 - 01.2014
Process Engineer - MES & SAP Deployment Lead
MSD Ireland
05.2009 - 08.2011
Site Lead for MES Deployment
Wyeth Pharmaceuticals
08.2005 - 05.2009
Compliance Specialist
Wyeth Pharmaceuticals
11.2003 - 08.2005
Manufacturing Supervisor
Wyeth Pharmaceuticals
07.1999 - 11.2003
Lab Analyst / Development Manager
Independent Analytical Services Ltd.
10.1995 - 07.1999
Batchelor of Science - Microbiology (Hons)
University College Cork