Supply Chain

Stuart McDonald

* ******* ***** ******, ** *****

Phone: 978-***-**** Email: ********@*****.***

Objective:

Continued growth utilizing my broad supply chain management expertise: I have 25 years experience in medical device manufacturing, pharmaceutical and biotech planning and scheduling, ERP integration and business process development. I’m highly customer focused; details oriented, and have a solid record of achievements.

Work History:

Logistics Manager - Autoliv Electronics America, Lowell, MA 06/11 -09/11

Lead facility Planning, Scheduling and Warehouse functions

Manage inventory levels in support of financial objectives

Improve customer and supplier on time delivery scorecard

Chair site production forecasting activity for EDI customers

Manage 5S and Layered Process Audits for Logistics function

Support new product launch and integration activities

Project Specialist - Shire HGT, Lexington, MA 12/08 - 05/11

Manage multi site ERP system enhancements

Integrate new manufacturing sites into ERP system modules

Validate ERP business and functional processes

Administer Production Control process and train incumbents

Provide second level support for ERP system related issues

Execute User Acceptance testing for system enhancements

Develop policy and procedure documents and deliver client training

Conduct system audits for agency compliance

Supply Chain Manager - Axsys Technologies, Inc., Nashua, NH 07/08 - 09/08

Manage site Purchasing, Warehouse Planning and Logistics functions

Implement monthly Sales Inventory & Operations Planning process

Establish supplier KPI metrics and inventory financial targets

Develop material supplier contacts to support production requirements

Lead supplier qualification initiatives, including selection and audit

Provide ERP system support for engineering change control

Supply Chain Analyst - Bristol-Myers Squibb Medical Imaging, Inc., Billerica, MA 09/01 - 04/07

Support inventory performance and risk reduction targets

Manage inventory control training and related metrics

Develop/validate ERP business and operations processes

Participate and respond to agency audit findings

Develop Sarbannes-Oxley risk mitigation processes

Master Scheduler - DuPont & DuPont Merck Pharmaceutical Co., Billerica, MA 1980 - 2001

Manage SIOP review and demand planning for clinical and commercial products

Lead packaging and labeling approval for European product launches

Manage CMO clinical/commercial demand and drug finishing schedules

Plan and procure all clinical/commercial drug product labeling

Demand schedule isotope irradiation cycles for production

Coordinate drug/device product test and shipping schedules

Project Achievements:

• Create training programs to drive inventory record accuracy to 98.8% saving $160k/year

• Design VMI control process for CMO, improving utility, saving $100k/year

• Convert outsourced finishing services to in plant, saving $800k/year

• Implement Sarbannes-Oxley controls meeting agency compliance saving $100k/year

• Develop standard material costing process reducing material cost variances to +/-5%/year

• Lead customer and supplier delivery, quality and quality metric improvement

• Design custom reports for operations and management data collection and reporting

• Develop GxPharma® document control process for FDA e-signature compliance

• Author more than 500 business policies, operating procedures and purchase specifications

• Respond to regulatory audits with CAPAs, processes changes and related training

• Develop labeling approval process, for Compliance, Operations, Quality and Regulatory

• Manage international regulatory approval for drug product labeling

• Develop ISOTrain® procedures, modules and curricula to track employee training history

• Validate ERP application upgrades and conduct system UAT

Education:

BS, Business Management program, Franklin Pierce College, Salem, NH

AS, Applied Science, Essex Technical Institute, Hathorne, MA

Certifications:

Applied Project Management Certificate, Boston University Corporate Education Center, 2009

Inventory Control and Cycle Counting Certificate, Rockhurst University, 2005

CPIM Certification, A-Z Training Consultants, 2006 - 2007

Sales Inventory & Operations Planning, Oliver Wight Int’l., 1993

MRP/MRP II Workshop, Oliver Wight Int’l., 1991

PC Applications:

Windows OS, MS Office 2007, 2010, MS Project, Access and Visio

Enterprise Applications:

AS/400 (BPCS, F3/Darth); SAP, J.D. Edwards; Ross ERP, Visual Manufacturing,

AMAPS, EZ Req, TrackWise, PTO Tracker, SOX Tools, GxPharma, Documentum, ISOTrain

Employer sponsored:

GMP Training; TrackWise; Sarbanes-Oxley Act; Business Excellence; Customer Service;

ISO; 5S; Lean Tools; Time Management; Civil Treatment for Employees; Workplace Violence

Prevention; Sexual Harassment; Radiation Safety Training; HAZMAT and Fire Safety Training

Personal:

President, New England Mountain Bike Association Merrimack Valley Chapter

Volunteer, Chelmsford Open Space Stewardship, Chelmsford, MA

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