Patrick Mulholland
Summary
Accomplished Supply Chain and Materials Management leader with expertise in procurement and logistics planning of clinical trial supplies. I have supported various therapeutic areas including Diabetes, Oncology, Metabolism, Respiratory, Infectious Disease and Vaccines. I possess extensive knowledge of GMP and cGMP requirements in clinical trial packaging, warehousing and distribution. Over twenty years of experience in moderate to high volume warehouse & distribution environments including five years pipeline manufacturing. Proficient in SAP, JD Edwards, Spectrum ERP systems
Overview
19
19
years of professional experience
Work History
Senior Supply Lead
Joule Scientific
03.2024 - Current
- Managed ancillary supplies for clinical trials within the Diabetes Therapeutic portfolio, across all sites from start-up to close-out.
- Created ancillary supplies budgets, generated purchase orders, and coded invoices for both the United States and Canada.
- Monitored participant enrolment to ensure clinical sites have sufficient supplies on hand for upcoming participant visits.
- Developed a supply tracker to consolidate Inventory, Distribution and Study Participant reports, which resulted in improved efficiency and cost savings.
- Accountable for quality, delivery, supplier performance, and establishing an appropriate supply replenishment process.
- Adhered to Sunshine Act requirements before sending supplies to sites.
- Monitored vendors to ensure purchase orders are delivered on time.
Vaccine Trial Supply Operations Manager
Capgemini Engineering
10.2020 - 02.2024
- Company Overview: Supporting Sanofi Pasteur
- Supported and provided tactical and operational oversight to the client trials.
- Executed Supply Master Plan defined by the CSC Project Manager for various clinical trials (nearly 13 Phase II/III/IV FLU, COVID, Meningitis clinical trials).
- Delivered key trial supply documentation (including writing, review, and approval as per effective procedures) such as the label specification form, packaging and distribution specifications, investigational product packaging order, and packaging instructions if any.
- Organized product transfers to the packaging unit of the products requested by Clinical teams, along with the associated documentation.
- Defined optimal shipment plans and tracked shipping activities so that clinical sites never run out of product.
- Coordinated the effort and delivery of the global reconciliation report after the product is returned to the packaging unit or depot from clinical trial sites.
- Quality control of documentation, as well as archival of trial supply documentation in accordance with the trial master file requirements.
- Setup, preparation, and facilitation of working sessions, including supply kick-off meeting with the key participants (trial managers, clinical logistics coordinator, clinical statistician, packaging unit coordinator, quality representatives, shipping unit representative) to streamline product flow management throughout the sourcing, packaging, distribution and reverse logistics of the product.
- Implemented quality control and product release activities.
- Provided weekly progress reports to the CSC Project managers in charge on the status of the supply to the clinical trial sites.
- Provided assistance during conflict resolutions within the CSC team and the clinical team.
- Supporting Sanofi Pasteur
Ancillary Supplies Coordinator
PRA Health Sciences
West Point, PA
10.2018 - 09.2020
- Managed day-to-day operations with external distribution facility (DHL/Exel) enduring GMP and cGMP requirements are met.
- Forecast, source and procure clinical ancillary supplies with preferred and third-party vendors.
- Manage initial, resupply and return shipments.
- Generate and analyze reports to track and review patient enrollment, screening, and supply strategies.
- Update various systems by associating and forecasting clinical ancillary supplies.
- Monitor study specific milestone data to create forecast and distribution plan.
- Conduct weekly operations meeting with team members to plan upcoming shipment and monitor/track incoming purchases.
- Create item masters and SASI (Site Ancillary Supply Item) document for each protocol.
- Proactively monitor inventory levels in the Ancillary Supplies inventory management system.
- Source and procure clinical ancillary supplies inclusive of medical equipment in coordination with multiple vendors.
- Monitor service for medical equipment and schedule new service with preferred vendors.
- Interface with vendors to source supplies and coordinate on time deliveries.
- 2019 PRA Local Knowledge Award Recipient
- Achieved an annual performance review of 'high' - top 5% of organization
- Completed bachelor's degree at Saint Joseph's University
- Selected by PRA management and the client (Merck) to take on the additional responsibility of managing the DHL/Exel external warehouse relationship, including day-to-day operations
- Proactively created a new process allowing dataloggers to be system allocated instead of manual tracking and allocation
- Increased the service level of ASM owned equipment to above 60% and met internal goal
- Mentored and trained new ASC's
Logistics Planner
PRA Health Sciences
West Point, PA
10.2014 - 10.2018
- Create and execute Purchase Orders in SAP SRM environment for Ancillary materials adhering to all GMP and cGMP requirements.
- Create and execute Ship Orders in Merck’s ERP system for clinical sites/Depots Domestic & International.
- Create and execute all returns related to Ancillary materials from Clinical sites in Merck’s ERP system.
- Create all Proforma/Commercial invoices in accordance with GMP and cGMP standards and the Country Requirements Database ensuring import compliance for all ASM international Shipments.
- Create a three month forecast of all ASM shipments.
- Coordinate the donations of Ancillary materials no longer needed for Merck clinical studies.
- Maintain Country Requirements Database Import/Export compliance.
- Liaise with country contacts to ensure Country Requirements Database meets all international regulatory compliance standards.
- Maintain ASM’s library of Proforma/Commercial Invoices ensuring they accurately reflect international standards as well as GMP and cGMP requirements.
- Resolve all delivery issues with Merck carriers to facilitate the final delivery or ASM shipments.
- Managed vendor relationship with The Standard Group
- Subject Matter Expert for SAP and The Standard Group
Materials Coordinator
Imperial Pipe Company
Riverside, CA
02.2014 - 08.2014
- Coordinate with Project Managers various needs for municipal/governmental projects.
- Generate Bill of Materials for multi-million dollar projects.
- Support company President and Engineering group and provide updates on status of materials.
- Build relationships with material vendors.
- Inspect all fabrication materials and ensure they meet blueprints and customer specs.
- Manage all fabrication materials and loose materials and ensure all materials are properly identified.
- Procure fabrication materials and ensure they are available for fabrication in a timely manner.
- Support project management.
Plant Receiver
Northwest Pipe Company
Adelanto, CA
08.2009 - 07.2013
- Inspect and manage all fabrication materials and loose materials to ensure they meet blueprints and customer specs.
- Ensure all materials are properly identified.
- Provide status updates on loose materials to production control manager.
- Make certain any and all loose materials are shipping with corresponding pipe.
- Saved approximately $30,000 by identifying a duplicate purchase order.
- Streamlined receiving process ensuring timely throughput of fabrication materials. This allowed fabrication departments to reduce material request lead time by 50%.
- Modernized documentation control of all vendor supplied receiving documentation.
Logistics Specialist
FARO Technologies, Inc.
Kennett Square, PA
07.2006 - 04.2009
- Primarily responsible for all incoming and outgoing Customer Service material.
- Act as back up for Production Receiving and Shipping Departments as necessary.
- Coordinate outbound logistics operations. Evaluate daily requirements and schedule accordingly.
- Monitor the resolution of shipping problems and issues that may involve packaging, damage, loss, delivery, billing or other means.
- Contact customs broker or shipping companies to investigate and resolve significant issues.
- Generate proper shipping documentation to ensure compliance with regulations and carrier requirements.
- Select shipping methods and appropriate carriers from among approved group, coordinating customer requests and scheduled deliveries.
- Identify and label shipments. Contact and schedule pick up of shipments by carriers and regulate pick up times to meet shipping schedules and maintain flow of materials and trucks in the dock area.
- Issue documentation to driver for signature.
- Maintain awareness of current import/export laws and procedures to insure compliance with all foreign and domestic regulations in conjunction with customs brokers.
- Maintain control of appropriate import/export documentation for shipments.
- Investigate and resolve discrepancies.
- Recommend and implement changes to approved processes and procedures.
- Decreased turnaround time for customer Retro-probe 100 & Retro-probe 400 by 75%.
Education
BBA - Business Administration
St. Joseph’s University
Skills
- GMP & cGMP Requirements
- Logistics Planning
- Materials Management
- Vendor Management
- Veeva Vault
- SAP
- JDE
- Spectrum
- 4G
- SOP Creation
- IRT Management
- Class II – V Controlled Substance Management
- Employee Supervision
- AWWA
- ANSI
- NSF Government Specifications
- Supply Chain Finance
- Procurement
Timeline
Senior Supply Lead
Joule Scientific
03.2024 - Current
Vaccine Trial Supply Operations Manager
Capgemini Engineering
10.2020 - 02.2024
Ancillary Supplies Coordinator
PRA Health Sciences
10.2018 - 09.2020
Logistics Planner
PRA Health Sciences
10.2014 - 10.2018
Materials Coordinator
Imperial Pipe Company
02.2014 - 08.2014
Plant Receiver
Northwest Pipe Company
08.2009 - 07.2013
Logistics Specialist
FARO Technologies, Inc.
07.2006 - 04.2009
BBA - Business Administration
St. Joseph’s University
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department or organization in order to identify areas for improvement or increased efficiency.</li> <li>Implemented quality control measures throughout each stage of a project's lifecycle.</li> <li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li> <li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li> <li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li> <li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li> <li>Trained junior staff on best practices for managing multiple projects simultaneously.</li> </ul> at Defense Contracting Activity, LLC<ul> <li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li> <li>Department of Agriculture (USDA) and the 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KIVA COLBERTKIVA COLBERT
SENIOR SUPPLY CHAIN PLANNER BUYER, TEAM LEAD at OPTIMAS OE SOLUTIONSSENIOR SUPPLY CHAIN PLANNER BUYER, TEAM LEAD at OPTIMAS OE SOLUTIONS