Summary
Overview
Work History
Education
Websites
Timeline
Generic

Maurice G. Phelan

Boston,MA

Summary

Life science leader with a deep sense of customer who is skilled in building high performance global teams that deliver. Owner of a broad network throughout the biopharma industry with expertise across major modalities and disciplines- large and small molecules, advanced therapies, drug product, fill and finish and packaging. A disciplined business builder, focused on quality with an excellent record in driving innovation, strategy execution and delivering growth.

Overview

38
38
years of professional experience

Work History

President & Chief Executive

Sartorius Stedim North America
01.2023 - Current
  • Development and execution of business, operational, and organizational strategy for two divisions of Sartorius driving critical share gain in both the Laboratory Products and Bioprocess Solutions businesses
  • Led all margin expansion, working capital improvement and cost management initiatives for Americas
  • Drove essential modifications and discipline into financial management workflows across the businesses creating accuracy, clarity and efficiency as we drove performance of P&L
  • Executive leader responsible for identifying and funding essential innovation projects launched first global innovation hub in Boston in Nov
  • 2024
  • Leader responsible for engaging local, state, and federal agencies to secure maximum public funding and tax incentives
  • Lead capital deployment and business development projects, M&A, and post-deal integration activities and ensure organization is ready for growth
  • Responsible for safety, quality and regulatory compliance across 26 sites the Americas region

Vice President, Fluid Management Business

Repligen Corporation
02.2022 - 10.2022
  • Integrated three businesses acquired in 2021 to form the new fluid management product portfolio
  • Built and qualified manufacturing sites in Waterford, Ireland, and Hopkinton, MA
  • Created a new business unit focused on single-use fluid management technology

Head of Life Science Operations North America

Sartorius Stedim Biotech
05.2018 - 02.2022
  • Led integration and operations for businesses acquired from Danaher Corporation
  • Led acquisition, integration and scale-up of newly acquired hollow fiber membrane business
  • Built and qualified the first NA manufacturing site for single-use cell culture and purification systems
  • Delivered bioprocess systems for Covid-19 vaccine manufacturing campaigns
  • Led design and roll-out of new ERP (SAP) and integration activities for new businesses
  • Managed North America expansion projects for GXP operations

Vice President, Pharmaceutical Operations

QPSI International
09.2015 - 10.2017
  • General manager responsible for product development, sales, marketing, quality systems, production, and regulatory affairs
  • Led investment in new GMP primary and secondary packaging operations
  • Developed and led new business strategy, delivering 80% revenue growth
  • Led M&A activities, including the acquisition of International Laboratories

GM Bioprocess Services & Enterprise Solutions

GE Healthcare
01.2013 - 09.2015
  • Global business leader with operational and P&L responsibility for GE's CDMO and Biopharma services organization
  • Developed and launched the KuBio modular biotech solution
  • Led global operations quality systems for biologics process development and clinical manufacturing
  • Completed lean six-sigma blackbelt program on assignment to GE Aviation and led multiple quality and business process improvement projects

Managing Director and Vice President - Pharma and Biotech Division

Validant
05.2011 - 01.2013
  • General manager with P&L responsibility for $100M Biopharmaceutical & Medical Device regulatory and consulting practices
  • Managed relationships with global regulatory agencies and delivered regulatory and compliance solutions

Director and Head of Compliance and Regulatory Affairs

Merck Millipore
04.1994 - 03.2011
  • Raised the technical and scientific presence of the Process Solutions Division with global regulatory agencies
  • Developed and executed the first regulatory strategy for Merck Millipore Division
  • Managed interactions with regulatory agencies and provided official commentary on draft regulatory guidance

Staff Chemist - Magnetic Resonance

Vital Sciences, Inc.
01.1992 - 01.1994
  • Participated in technology transfer and commercial scale-up of magnetic resonance technology
  • Designed and executed software validation plans for LIMS and automated equipment

Staff Chemist - Transplant Research, Harvard Medical School

The Children's Hospital
08.1987 - 01.1992
  • Developed clinical chemistry assays for investigational new drug treatment protocols
  • Evaluated and validated new rapid diagnostic equipment for critical care units

Education

B.Sc. - Chemistry

National University of Ireland Maynooth

B.Sc. - Experimental Physics

National University of Ireland Maynooth

Timeline

President & Chief Executive

Sartorius Stedim North America
01.2023 - Current

Vice President, Fluid Management Business

Repligen Corporation
02.2022 - 10.2022

Head of Life Science Operations North America

Sartorius Stedim Biotech
05.2018 - 02.2022

Vice President, Pharmaceutical Operations

QPSI International
09.2015 - 10.2017

GM Bioprocess Services & Enterprise Solutions

GE Healthcare
01.2013 - 09.2015

Managing Director and Vice President - Pharma and Biotech Division

Validant
05.2011 - 01.2013

Director and Head of Compliance and Regulatory Affairs

Merck Millipore
04.1994 - 03.2011

Staff Chemist - Magnetic Resonance

Vital Sciences, Inc.
01.1992 - 01.1994

Staff Chemist - Transplant Research, Harvard Medical School

The Children's Hospital
08.1987 - 01.1992

B.Sc. - Chemistry

National University of Ireland Maynooth

B.Sc. - Experimental Physics

National University of Ireland Maynooth

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Maurice G. Phelan