Thomas Synnott
Madison,CT
Summary
An energetic, motivated, and highly dynamic person with strong working skills and a broad range of hands-on and theoretical experience in many areas. Responsible for restructuring the company's Purchasing and Supply Chain functions to make them as effective and efficient as possible. Expert in completing demanding assignments within crucial timelines. Highly articulate, demonstrating excellent interpersonal skills. Strong management skills and methodical aptitude with an innate ability in decision-making, coordinating, and synthesizing data.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Associate Director Clinical Planning and Logistics
Alexion Pharmaceuticals, Inc.
04.2022 - Current
- End-to-End Supply Planning
- Working together with demand planning, developing and optimizing supply models, and defining manufacturing production schedules based on overall program knowledge and capabilities, including but not limited to technology-specific limitations, product shelf-life, manufacturing timelines, development activities, and regulatory requirements.
- Recommend short-term and long-term strategic clinical manufacturing plans to enable Clinical Trial execution at all phases of development for assigned programs
- Run production planning scenarios anticipating potential hurdles and identify mitigations
- Clinical S&OP Management
- In partnership with Clinical Supply Leads for assigned programs and Demand Planning, establish &maintain Clinical Supply Portfolio MRP/LRP
- Partner closely with Global Supply Chain to produce and publish consolidated S&OP, enabling collaborative & seamless management of clinical supplies for late-phase assets and Global Capacity Planning across the Astra-Zeneca - Alexion Rare Disease Business Unit.
- Logistics and Warehouse Management
- Coordinate cGMP cold chain shipments of clinical cell banks, Drug Substances, Drug Products, and Finished Products to supply depots for internally and externally manufactured products.
- Establish and track KPI metrics to evaluate internal and external logistics performance
- Negotiate favorable shipping and storage agreements, project plans, and statement of work documents with external partners based on agreed-upon priorities from critical clinical and commercial stakeholders within the organization.
Senior Manager Global Clinical Supply
Alexion Pharmaceuticals, Inc.
10.2019 - 06.2022
- Direct/oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on-time delivery to support clinical trials.
- Leads the planning, creation, and maintenance of IMP supply project plans, based on study forecasts with Clinical and Medical project managers and contract providers.
- Manage Quality Systems required documentation, including on-time open and close of Deviations, Investigations, CAPA’s, Change Controls, Labels, and Product Specifications, and others as required.
- Evaluate, select, and implement contract manufacturing, packaging, and labeling operations
- Negotiate supply/technical agreements, oversee operations, and act as primary liaison between clinical personnel and contractor(s) on assigned projects.
- Identifies process improvement opportunities, recommends pathways for solutions, and drives idea generation, proposals, and implementation.
- Direct and monitor clinical supply contractor set up, progress, and implement corrective actions when issues arise.
- Manages development and implementation of IVRS supply and drug return strategy with contractors and sites.
- Manages Clinical Supplies inventory for projects assigned by interfacing with contractors to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed
- Interacts with Clinical sites, caregivers, and patients regarding supply needs, storage, and return of clinical supplies.
- Ensures that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
- Proactively drives cross-functional activities
- Works with other line functions and external partners to manage complex projects.
- Participates as SME for clinical regulatory audits related to supply.
- Represents Clinical Supplies on global clinical project teams.
Supply Chain Manager
Virscio
03.2018 - 10.2019
- Led the clinical supply chain sourcing of active pharmaceuticals, device components, and bulk chemicals for both clinical and commercial materials
- Evaluate and qualify new suppliers, audit current suppliers, and secure second sourcing opportunities
- Created and implemented development activities in logistics and sponsor service in the US and Europe aligned with future growth
- Identified and restructured a new logistic process and created relations with government entities to ensure a streamlined supply chain for clinical materials and life science shipments
- Acquired new temperature-controlled logistics system and packaging to ensure the integrity of every shipment
- Remodeled new freight forwarding process and carriers to best suit company direction
- Introduced vendor scorecards to measure and analyze supplier performance and applied new methods in forecasting materials
- Created & assisted in the development of standing operating procedures for supply chain operations
Operations and Logistics
World Courier
04.2010 - 07.2017
- Leading and implementing the regional clinical supply chain shipments
- Maintained knowledge and practice of global GxP Standards and Regulations, including compliance in temperature controls (Cold Chain) and products
- Liaised regularly with doctors, scientists, and customs officials to ensure a positive representation of the company
- Maintained and improved customer relations with the existing client base
- Managed staff on updating CRM systems, monitoring shipments to resolve issues proactively
Director Of Operations
Parkside
01.2001 - 03.2010
Education
Bachelor's degree - Business Administration and Management, General
Dublin City University
01.2004
Skills
- Accounting
- Logistics Management
- Strategy
- GxP
- Forecasting
- Life Sciences
- Pharmaceuticals
- Supply Chain Management
- Customer Relationship Management (CRM)
- Supply
- Database coordination
- Process Improvement
- Crisis Management
- Project Management
- Budget Management
- Operations Management
- Team Collaboration and Leadership
Certification
- Life Sciences Passport - World Courier
- Six Sigma Yellow Belt - Etac
Awards
- Living The Values - Clinical Development Leadership Team, 02/2021, Thank you for your dedication and relentless efforts to identify innovative solutions to overcome obstacles during a pandemic and support the enrollment of patients in ALXN1210MG-306. The cross-functional collaboration for this program was extraordinarily efficient, and your contribution was key to its success.
- Living The Values - Paul Tamburini, 12/2020, The hard work and dedication demonstrated toward driving ALXN1820, an exciting new molecule, into the clinic. Thank you so much.
- Living The Values - Betsy Cohen, 05/2021, Tom's dedication, diligence, and ability to quickly assess new scenarios, has been a tremendous help to ensuring the success of Phase 1 clinical plans for early program assets. Thank you so much! Betsy.
Accomplishments
Honors & Awards
Living The Values - Clinical Development Leadership Team
Feb 2021
Thank you for your dedication and relentless efforts to identify innovative solutions to overcome obstacles during a pandemic and support the enrollment of patients in ALXN1210MG-306. The cross-functional collaboration for this program was extraordinarily efficient, and your contribution was key to its success.
Thank you again for your continued commitment to finding new solutions for our patients! Clinical Development Leadership Team (Gianluca Pirozzi, Yoshie Fujita, Xiang Gao, Laura Gault, Melissa Haskell, Anita Hill, Michele Mercuri, Raj Pradhan, Scott Rottinghaus).
Living The Values - Paul Tamburini
Dec 2020
The hard work and dedication demonstrated toward driving ALXN1820, an exciting new molecule, into the clinic.
Thank you so much.
Living The Values - Betsy CohenMay 2021
Tom's dedication, diligence, and ability to quickly assess new scenarios have been tremendous help in ensuring the success of Phase 1 clinical plans for early program assets. Thank you so much! Betsy.
Timeline
Associate Director Clinical Planning and Logistics
Alexion Pharmaceuticals, Inc.
04.2022 - Current
Senior Manager Global Clinical Supply
Alexion Pharmaceuticals, Inc.
10.2019 - 06.2022
Supply Chain Manager
Virscio
03.2018 - 10.2019
Operations and Logistics
World Courier
04.2010 - 07.2017
Director Of Operations
Parkside
01.2001 - 03.2010
Bachelor's degree - Business Administration and Management, General
Dublin City University
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