John McGregor

Work History

Senior Manager, Logistics and Distribution

Vertex Pharmaceutical Incorporated

11.2021 - Current

Cell and Gene Therapy global logistics operational lead responsible for planning and execution of time critical cold chain shipments in support of Vertex's Cell and Gene therapy programs
Key responsibilities include end to end management of clinical study shipments and real-time tracking and troubleshooting of issues
The Senior Manager works closely with couriers, Clinical Operations, CMO scheduling staff, QA and other stakeholders to plan and execute shipments
In addition to management of clinical shipments the Senior Manager will assist the Logistics Director in establishing the Cell and Gene Therapy commercial logistics capabilities.

Senior Manager, Supply Chain

Dyne Therapeutics Incorporated

06.2021 - 11.2021

Manage CMOs to deliver study material on time and within budget
Establish and manage contracts and supply agreements and manage CMOs
Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis
Lead process improvement initiatives and author clinical supply SOPs
Enable successful clinical trials using supply chain management processes (Plan, Source, Make, Deliver, and Return)
Responsible for integrated project management of all CMC vendors ensuring all stakeholders support inventory required to fulfill research, pre-clinical and clinical needs
Responsible for storage and shipping of all pre-clinical and clinical intermediates, domestic and international
Set up a commercial supply chain prior to BLA
Responsible for drug product activities related to manufacture and clinical distribution
Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
Support the development of regulatory CMC documentation and partner due diligence
Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target time frames
Provide patents and creative ideas to provide protection or creation of new or better products or processes.

Supply & Logistics Manager

Agenus, Inc.

09.2016 - 06.2021

Execute and oversee the physical and administrative tasks for inventory management of materials, intermediates, final products, and test samples in support of GMP operations for Both our Cell Gene Therapy and Antibody studies through Pre IND, IND and BLA
Oversee and arrange for the receipt of materials and product in a timely manner ensuring careful handling of critical and temperature sensitive materials
Oversee and coordinate the timely and efficient movement and shipment of materials and product for GMP purposes and in compliance with IATA and 49 CFR DOT regulations
Process the receipts, movement, status change and storage of inventory via SOPs, inventory tracking systems and ERP systems
Manage all metrics for the S&L department and provide monthly status reports to upper management
Oversee and support the document planning, packaging, shipping and distribution of inventory to internal departments, test labs, clinical sites, customers and vendors for both domestic and international R&D and Administrative shipments for Agenus Lexington, Agenus South, Agenus UK and Agenus Subsidiaries
Oversee international release documentation requirements and mitigate risk for shipments as the subject matter expert in the latest guidelines on import and export regulations
Ensure security and accountability of materials and product inventory, assist with validation of temperature-controlled storage units and perform routine cycle counting in support of SOX compliance
Monitoring of temperature storage equipment on and off-shift and responding to alarm events and ensure secure storage of materials and product
Identify cost savings opportunities for the company and leverage vendor expertise for shipments, packaging and logistics services
Manage Supply & Logistics personnel and conduct routine check ins, manage training, set goals and conduct annual reviews.

Lead Materials Control

Biogen

09.2014 - 09.2016

Assisted in the organization, delegation and processing of the receiving, labeling and shipping tasks of all applicable materials on a day to day basis
Created an organized plan for internal processing of items and prioritizing daily functions need and manpower for optimal process flow
Ordered supplies affiliated with operations and created minimum reorder points for necessary items
Assisted in screening and managing all email notifications, questions and alerts from internal and external customers
Processed all items related to shipping invoices
Daily use of shipping manifests and LTL carriers
Created Standard operating procedures and job aids for operational functions
Assisted in the Management of the non GMP Shipping and Receiving team.

Hazardous Materials Coordinator

Key Polymer

08.2011 - 09.2014

Organized daily shipping responsibilities
Hazardous waste storage and disposal
Applicable shipping and hazardous documentation, (FICA, BOL, NAFTA, COA, MSDS, COI)
Created profiles and distinguishes products chemical class and shelf life
Managed warehouse floor and inventory of all supplies affiliated with operations
Incoming and outgoing raw materials and finished products
Incoming and outgoing invoices
Stored and entered information via ERP system and Crystal Reports software
Daily use of shipping manifests and LTL carriers
Managed all RA materials and locations
In-house lead in Toughseal product demo workshops and applications
Certified in all DOT, IATA, IMDG safety and CFR regulations including Hazardous waste disposal: Per RCRA and DOT standard operations.

Operations Assistant

Light River Technologies

06.2009 - 07.2011

Created Standard Operation Procedures for RMA, Shipping, Receiving, Drop Ship, Internal RMA operations
Created bin system for storing all inventory
Handled all shipping and receiving responsibilities (average 600 items per day)
Tracked all items with Tracer 2 scanning software (average 2400 scans per day)
Managed warehouse using Dashboard and Dynamics SL ERP systems
Filed and stored all applicable records
Quoted and handled all freight carriers
Assisted in creating Lab setup for demo location
Handled all R.MA
(Return Material Authorization).

Lead Shipper/Receiver

Scandius Biomedical/Covidien

01.2003 - 07.2008

Received products, filed into applicable locations, created quarantine labels, and entered into ERP
Created bill of material for all products, packaged and issued labor and lot numbers to individual products
Issued material, job labor to accounting and moved into applicable stock area after QC approval
Managed all RMA material per SOP procedures
Autoclave product, cidexed and released paperwork to sales and QC
Pulled and packaged all shipping orders, both domestic and international
Assisted R&D in any pull testing, autoclave testing, sizing fixtures and drill depth finding
Created fixture for R&D saw bones testing
Assisted manufacturing in all builds per S.O.P procedures
Ordered all supplies needed in-house per shipping and office.

Summary

Overview

Work History

Senior Manager, Logistics and Distribution

Senior Manager, Supply Chain

Supply & Logistics Manager

Lead Materials Control

Hazardous Materials Coordinator

Operations Assistant

Lead Shipper/Receiver

Education

Associates Degree - Business Transfer

No Degree - Business Administration And Management

Skills

Timeline