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PATRICIA M. BRADY 320 Russell Street

Carlise, MA 01421 Cell phone: 858-531-7812 Email: pat_brady@yahoo.com

www.linkedin.com/pub/patricia-brady/11/473/b5b/

PROFESSIONAL SUMMARY

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 achieve results.

CORE COMPETENCIES

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 management.

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 regulations

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

PROFESSIONAL EXPERIENCE 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 25%.

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.

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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.

Sequenom Inc., 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

year 2014.

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.

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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 milestones.

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 metrics.

Prior experience:

Held positions of increasing responsibility in manufacturing and end to end supply chain management at commercial manufacturing companies for drug, device and diagnostic products.

EDUCATION

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 Association).

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