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PATRICIA M. BRADY
320 Russell Street
Carlise, MA 01421
Cell phone: 858-531-7812 Email: email@example.com
Senior Supply Chain leader with extensive experience and proven results in end to end supply chain
management in the biotech, pharmaceutical, medical device and diagnostics business sectors.
Experienced with developing supply chain management infrastructure and implementation of strategic
supply chain functions from materials and equipment sourcing, supplier negotiation and procurement,
production and material planning, ERP system implementation / upgrade, inventory, warehouse, shipping,
receiving, CMO management, cold chain logistics, and 3PL management in clinical and commercial
manufacturing operations. An effective leader with proven ability to develop and motivate teams to
Execution of commercial pharmaceutical
drug product launches in the U.S. and EU
Experienced with preparation of material
sections of NDA and IND preparation
Successful leadership of planning, inventory,
warehouse operations and cross functional
teams (e.g. Six Sigma, production planning)
Development and execution of artwork and
labeling in support of NDA applications
Leadership of sourcing, contract negotiation
and procurement operations for R&D,
process development, process scale up,
cap ex, and GMP materials
GMP supplier qualification program
CMO selection and management of
packaging and labeling operations.
Clinical supply chain leadership,
management of CMO’s, label development,
IVRS and logistics
Implementation of CMC supply chain
strategy, S&OP process, material and
production planning systems, ERP
Cold chain product logistics, packaging and
shipping container development, execution
of IQ, OQ and PQ validation
Knowledgeable of Import and export
100% compliance with audits performed by
FDA, EMEA, MHRA, DEA and FAA
EHS manager for 2 years at a
manufacturing site - developed company
safety policies, internal audits
Flexion Therapeutics – Burlington, MA Sept 2015 - Present
Sr. Manager of Supply Chain
Manage clinical supply chain network, label development, package design and inventory to assure all
clinical operations milestones are achieved and on time. 3 trials to date are completed on time with good
results. Start-up activities for a large scale 2017 trial are completed.
Develop innovative ways to prepare packaging and labeling CMO to reduce timeline requirements by
Manage sourcing and selection process for new clinical packaging, labeling and distribution CMO.
Selection process resulted in qualification of best CMO for quality, cost and global network.
Provide key NDA support to sections related to materials and suppliers. Acquired technical documents
and letters of authorization for DMF from suppliers. Established Master Supply Agreements.
Supplier relationship management for components and implementation of Mass Bio discount programs
for support of new offsite laboratory facility that will result in a projected 40% cost savings for 2017.
Provide input to strategic planning decisions and broader cross-functional decisions.
Managed logistics operations for 6 months prior to addition of a dedicated Logistics Manager.
PATRICIA M. BRADY
Alexion (Synageva), Lexington, MA (company purchased, Supply Chain in EU only)
May 2015 – August 2015
Associate Director of Commercial Supply Chain
Led the commercial launch of packaging and labeling operations for Kanuma in the U.S. and EU.in Q3 of
2015. Created detailed time lines and activity performance tracking to assure projects were on schedule.
Managed labeling and packaging CMO’s in the U.S. and U.K. including validation activities, package
design and artwork development for a global product launch.
Managed effort to create a commercial MSDS for product.
Responsible for the implementation of the S&OP process.
Developed and implemented commercial supply chain processes in support of product launch.
Retrophin, San Diego, CA (reduction in staff) May 2014 – January 2015
Associate Director of Procurement and Materials Management
Directed activities related to supply chain management including material sourcing, contract
manufacturing relationships, clinical supply management and logistics for rare disease drugs.
Provided supplier based solutions to product development, analytical and commercial operations
including a path to procure DEA schedule 3 drugs.
Executed the UAT of VEEVA EDMS Submission Vault as the designated CMC member of the team.
Bioserv Corporation, San Diego, CA (3 mo. temp assignment) March 2014 – May 2014
Consulting Position - Head of Supply Chain Management
Performed risk assessment and gap analysis reports identifying significant weaknesses in procurement
and supply chain.
Provided and implemented best practices for purchasing and inventory management.
Renovated the entire procurement system improving functionality, utilization of ERP software and 100%
reduction in AP backlog.
SequenomInc., San Diego, CA (50% reduction in staff) July 2013 – March 2014
Director of Procurement, Materials and Supply Chain Management
Directed activities for procurement, strategic sourcing, receiving, master scheduling, production and
materials planning, inventory control, warehouse operations, logistics and distribution. Responsible for
managing distribution of test kits and inbound blood samples for DNA sequencing.
Completed process mapping and GAP analysis of logistics. Implemented changes to inbound shipments
that resulted in a $1.2 million annual savings. Identified $5 million of potential logistics savings and a $400K
reduction in contract packaging cost contributing to the company achieving profitability at the end of fiscal
Improved the efficiency of the procurement process by 25% through greater utilization of SAP module,
improved collaboration with internal customers.
Established optimized process flows, standard operating procedures, best practices, and metrics resulting
in a 50% decrease procurement process cycle as well as 100% compliance to SOX requirements.
Reduced open purchase order backlog by 100%. Improved the accuracy of the invoice vs. PO process.
Generated $400K in cost savings through negotiations with major suppliers.
Completed process mapping of functions and GAP analysis of the logistics process.
PATRICIA M. BRADY
PACIRA PHARMACEUTICALS, San Diego, CA March 1995 to July 2013
Senior Manager Supply Operations
Directed end to end supply chain functions including procurement, strategic sourcing, receiving, master
scheduling, S&OP process, production and materials, planning, inventory control, warehouse operations and
distribution of pharmaceutical products.
Created SOP’s for supply chain operations, procurement, inventory management, receiving, warehouse and
logistics to comply with FDA, EMEA, MHRA, GMP, DEA and SOX requirements.
Identified supply sources for qualification of all raw materials including rare API’s and novel excipients and
developed material specifications.
Developed supply chain contracts and quality agreements with suppliers and CMO’s. Negotiated long term
supply agreement to secure the supply base.
Responsible for execution of supply chain, cold chain logistics and manufacturing strategies to successfully
launch 3 commercial products in the U.S. and EU. Provided essential supplier information and labeling
artwork to support IND, NDA and EMEA applications.
Directed planning and execution of clinical supply packaging and shipping operations to support clinical supply
Delivered innovative procurement solutions and significant cost savings to internal customers resulting in an
average of $5 million per year. Responsible for companywide procurement and capital expenditures.
Managed CMO’s in U.S. and EU for clinical and commercial packaging. Responsible for all artwork
management. Primary contact with marketing and sales partners in the U.S. and EU.
Led packaging engineering projects to design, develop, validate and execute unique packaging and shipping
containers for 2-8’ C temperature sensitive products. Expertise with cold chain logistics.
Subject matter expert for enterprise software implementation, execution and supporting validation activities.
Implemented S&OP process, master scheduling, MRP, production scheduling and monthly operations
Held positions of increasing responsibility in manufacturing and end to end supply chain management at
commercial manufacturing companies for drug, device and diagnostic products.
Bachelor of Arts, Psychology - University of California at Los Angeles, Los Angeles, CA
MBA program at University of Phoenix for 1.5 yrs.
Certificate in Project Management and EHS, University of California at San Diego
APICS certified CPIM (Certified Production and Inventory Manager, CSCP certification in process
Member of APIC’s (American Production and Inventory Control Society), PDA (Parenteral Drug