Craig Duffy
Andover,MA
Summary
Accomplished Director at Moderna with expertise in organizational development and strategic planning, leading the successful mRNA-1273 program to enhance supply chain efficiency and compliance. Demonstrated leadership fostered team growth and process improvements, combining hard and soft skills effectively. Proven ability to navigate complex regulatory landscapes and drive operational excellence. Dedicated to leveraging these competencies for continued advancements in biopharmaceutical innovation.
Overview
18
18
years of professional experience
Work History
Director, Clinical Drug Supply Operations
Moderna
Cambridge, Massachusetts
01.2022 - Current
- Serve as Clinical Drug Supply lead for mRNA-1273 (Covid-19 vaccine) program and Autoimmune Indications and act as the primary supply liaison for cross functional leads within CMC, Quality Assurance, Regulatory Affairs and Clinical Development
- Lead weekly and ad-hoc all-hands Therapeutic Area meetings for internal, cross functional teams to ensure supply risks and opportunities are documented in a supply dashboard
- Collaborate with Finance and lead budget function for Clinical Drug Supply and developed a budgeting process and system enabling the ability to produce accurate budget projections and accrual tracking
- Assist in creating department goals, evaluate issues and roadblocks facing the function and provide strategic guidance both internally to the function and with cross functional teams
- Lead and own group business processes including designing, drafting, reviewing, and approving SOPs
- Actively contribute to multi-year supply agreement negotiations with external vendors
- Ensure all clinical supply documents and procedures are inspection-ready at all times; implemented group strategy for GxP inspection readiness by directing internal self-audit program
- Determine hiring plan for group in conjunction with senior leadership; mentor, coach and develop direct reports, evaluate project assignments and bandwidth for team
Senior Manager, Clinical Supply Chain Operations
Blueprint Medicines
Cambridge, Massachusetts
12.2017 - 01.2020
- Performed demand planning for the manufacturing of clinical trial material (drug substance through finished good) to support global clinical trials using a pooled supply strategy for studies in phases 1-3
- Conducted capacity planning to ensure a seamless and uninterrupted supply of Drug Substance/API and Drug Product among 6 Contract Manufacturing Organizations (CMOs)
- Enabled pilot program of the integration of Endpoint’s DRIVE and PULSE IRT systems to synchronize supply, randomization and dispensation modules
- Engaged with internal customers such as Clinical Operations, Regulatory Affairs and CMC groups by leading forward-looking supply team forums to proactively identify and mitigate supply risks
- Managed accrual and forecasted spend of distribution and secondary production activities
Manager, Clinical Supply Chain
Ironwood Pharmaceuticals
Cambridge, MA
05.2017 - 12.2017
- Designed and executed clinical packaging and labeling campaigns by translating clinical protocol data to delivery of clinical supplies to ensure new study timelines and ongoing resupply campaigns were achieved
- Managed issue escalation, contract negotiation and review with selected CMOs
- Created new Standard Operating Procedures for the Clinical Supply Chain function working closely with Quality Assurance
Senior Manager, Supply Chain
Acceleron Pharma
Cambridge, Massachusetts
03.2016 - 05.2017
- Maintained long-term manufacturing forecast and drug supply strategy for global clinical trials in Phases 1-2
- Managed annual department budget of $8.7M
- Tracked actual and projected spend
- Lead initiatives for generation, refinement and maintenance of clinical supply infrastructure and cross-functional collaboration
- Developed business relationship with existing CMO and evaluated proposals to integrate with a second CMO; established metrics tracking program to ensure timelines, budgets and performance were measurable between suppliers
Manager, Clinical Drug Supply
Biogen
Cambridge, Massachusetts
01.2014 - 03.2016
- Developed and maintained study level finished good demand plans and monitored supply performance in multiple global clinical trials in phases 1-3
- Acted as department lead to support GXP regulatory inspections and created department inspection readiness process to support future inspections and internal audits
- Hired, mentored and coached direct reports to ensure department and professional development goals were achieved
Specialist, Global Transport, Logistics & Customs
adidas-Group
Canton, Massachusetts
09.2007 - 10.2011
Supply Chain Coordinator
INTRAL Corporation
Boston, Massachusetts
09.2006 - 09.2007
Education
Master of Business Administration -
Assumption University
Worcester, Massachusetts01.2011
Bachelor of Arts - Spanish
Saint Michael’s College
Colchester, Vermont01.2006
Academic year abroad -
Universidad de Salamanca
Salamanca, Spain05.2005
Skills
- Organizational development
- Employee development
- Business strategy
- Team management
- Process improvement
- Regulatory compliance
- Operations management
- Strategic planning
- Logistics management
Volunteer Experience
- Saint Michael’s College, Colchester, VT, Member of the Board of Trustees, 08/01/19, 06/30/21, The Saint Michael’s College Board of Trustees is the governing body of the college, responsible for strategic planning and oversight of committees and offer advice and counsel to the college’s President. The Board of Trustees is responsible for all fiduciary and legal decisions and developing the college’s strategic mission and establishing programs and policies.
- Saint Michael’s College, Colchester, VT, President, Alumni Association Board of Directors, 09/01/13, 06/30/19, The Saint Michael's College Alumni Board of Directors is a working board that is committed to assisting the college in three important areas: Admissions, Career Development, and Alumni Relations. Board members strive to positively impact alumni, parent and student programs in these specific areas, while still maintaining and strengthening the strong bonds of friendship and loyalty that exists among the college's graduates.
Timeline
Director, Clinical Drug Supply Operations
Moderna
01.2022 - Current
Senior Manager, Clinical Supply Chain Operations
Blueprint Medicines
12.2017 - 01.2020
Manager, Clinical Supply Chain
Ironwood Pharmaceuticals
05.2017 - 12.2017
Senior Manager, Supply Chain
Acceleron Pharma
03.2016 - 05.2017
Manager, Clinical Drug Supply
Biogen
01.2014 - 03.2016
Specialist, Global Transport, Logistics & Customs
adidas-Group
09.2007 - 10.2011
Supply Chain Coordinator
INTRAL Corporation
09.2006 - 09.2007
Master of Business Administration -
Assumption University
Bachelor of Arts - Spanish
Saint Michael’s College
Academic year abroad -
Universidad de Salamanca
Similar Profiles
Cara WardonCara Wardon
HR Partner, CMC at ModernaHR Partner, CMC at Moderna
Phani K BalagamPhani K Balagam
Sr Manager, Analytics Engineering at ModernaSr Manager, Analytics Engineering at Moderna
Abby RufusAbby Rufus
Global Clinical Operation Lead at ModernaGlobal Clinical Operation Lead at Moderna