William Cloutier
Cambridge
Overview
15
15
years of professional experience
Work History
Associate Director, Manufacturing
IPSEN Biopharmaceuticals
09.2022 - Current
- Serve as a key member of the Site Leadership Team (SLT), contributing to site strategy, cross-functional collaboration, and improvement initiatives
- Lead, develop, and mentor a high-performing team, ensuring skill development and engagement
- Act as the regulatory host for inspections, delivering opening remarks, facility tours, and scribe duties
- Drive a culture of accountability and continuous improvement through structured team engagement and performance feedback
- Oversee site decommissioning strategy, ensuring seamless transition and change management
- Manage budget planning, financial tracking, contract negotiations, and tactical execution of manufacturing operations
- Develop and negotiate manufacturing service and supply agreements in collaboration with Legal, Finance, Procurement, and Quality teams
Manager, Manufacturing
IPSEN Biopharmaceuticals
06.2020 - 09.2022
- Led site manufacturing operations, ensuring compliance, safety, and efficiency in alignment with supply plans
- Developed and executed the manufacturing master schedule in collaboration with Supply Chain
- Established and tracked KPIs, including First Time Quality, deviation closure rates, and CAPA completion
- Served as Manufacturing Subject Matter Expert (SME) for regulatory inspections, providing both front- and back-room audit support
- Supported technology transfer projects to ensure successful implementation and scalability
Supervisor, Manufacturing
IPSEN Biopharmaceuticals
05.2017 - 05.2020
- Managed a team of Manufacturing Associates, ensuring adherence to cGMP and production schedules
- Designed and optimized training programs to enhance operational efficiency and compliance
- Acted as SME for manufacturing equipment and regulatory audits, ensuring seamless inspection readiness
- Led quality system records management, including deviation investigations, CAPA resolutions, and change control implementation
- Championed continuous improvement initiatives through cross-functional collaboration and process optimization
- Supported technology transfer activities, ensuring successful process adoption
Manufacturing Associate III
IPSEN Biopharmaceuticals
04.2017 - 05.2017
- Transitioned from Merrimack Pharmaceuticals to Ipsen as part of the Onivyde acquisition, maintaining responsibilities in manufacturing and process support
Manufacturing Associate
Merrimack Pharmaceuticals
03.2014 - 04.2017
- Supported late-stage development and commercial production of nano-liposomal therapeutics
- Led commissioning, qualification (OQ/PQ), and validation activities for manufacturing suites
- Executed engineering (ENG) and process performance qualification (PPQ) batches, contributing to FDA preapproval inspections and successful regulatory approvals
- Managed end-to-end manufacturing processes, including solution preparation, formulation, and filtration
- Reviewed batch records for compliance, ensuring accuracy and GMP adherence
- Led investigations for quality events (QIs), CAPAs, and change control initiatives
Manufacturing Associate
Genzyme Corporation
03.2013 - 03.2014
- Operated and trained personnel in upstream clarification and downstream purification processes
- Conducted critical operations within Biological Safety Cabinets (BSCs) to maintain aseptic conditions
- Performed chromatography column packing and qualification
- Managed tangential flow filtration (TFF) ultrafiltration/diafiltration processes
- Developed and revised SOPs to enhance clarity and regulatory compliance
- Led training initiatives, including on-the-job training (OJT) and curriculum development
- Implemented SharePoint tools to improve cross-functional communication
Senior Manufacturing Technician
Genzyme Corporation
09.2011 - 03.2013
Manufacturing Associate
Alexion Pharmaceuticals
01.2010 - 01.2011
- Specialized in downstream purification processes for commercial and clinical products
- Operated AKTA Process Chromatography Skids and ultrafiltration systems
- Conducted CIP/SIP, solution transfers, pH adjustments, and in-process testing (A280)
- Maintained detailed batch records for regulatory compliance
- Contributed to safety audits and continuous improvement initiatives
Education
MBA -
University of Massachusetts, Lowell
Lowell, MA05-2025
Skills
- Project management
- Strategic leadership
- Analytical thinking
- Coaching and mentoring
Timeline
Associate Director, Manufacturing
IPSEN Biopharmaceuticals
09.2022 - Current
Manager, Manufacturing
IPSEN Biopharmaceuticals
06.2020 - 09.2022
Supervisor, Manufacturing
IPSEN Biopharmaceuticals
05.2017 - 05.2020
Manufacturing Associate III
IPSEN Biopharmaceuticals
04.2017 - 05.2017
Manufacturing Associate
Merrimack Pharmaceuticals
03.2014 - 04.2017
Manufacturing Associate
Genzyme Corporation
03.2013 - 03.2014
Senior Manufacturing Technician
Genzyme Corporation
09.2011 - 03.2013
Manufacturing Associate
Alexion Pharmaceuticals
01.2010 - 01.2011
MBA -
University of Massachusetts, Lowell
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