Dennis J. Bly, CPIM
Ventura, CA 93001
*********@*******.***
Summary
A dynamic leader with strong operations management skills, and the proven ability to motivate and inspire employees to perform at a high level. With over 25 years of managing people and processes, repeatedly demonstrated the ability to improve manufacturing operations. Excellent ISO and cGMP knowledge allow me to excel with in a Quality Systems environment. Superior Soft Skills allow me to build high performance cross-functional teams and to improve interdepartmental communication.
Lean Green Belt Certified International Business Experience
Employee Development Capital Equipment Purchasing
Team Building Quality Control/Assurance
Supply Chain Plant Relocation/Closure
Facilities Management Process Improvement
cGMP/ISO Equipment Maintenance
Scheduling Validation
Materials Management Training/Facilitation
Career Experience
2013- Jan 2017, Shire LLC, Glendale Ca
Manufacturing Supervisor II
In the last 18 months successfully transitioned from the supervision of Albumin purification to supervision of the Factor VIII purification department, managing Mab column chromatography as well as ion exchange column purification. Key deliverables are adherence to schedule, maintaining a safe work environment, minimizing compliance issues and ensuring staff training requirements are met. Accomplishments include:
-Resolved Hyclone box issues through Kaizan Methodology.
-Took APD Swing shift from Good to Great, via coaching and hiring practices.
-Resolved chronic potency buffer failures.
-Successfully completed Lean Green Belt training.
2010-2012 CSM,LLc, Mendon NY
Internet Sales and Warehouse Manager
In an entrepreneurial environment created and managed data base that provided the basis from which an on-line store operated. Wrote operating procedures for all aspects of business and was responsible for all internet customer service interactions. Grew Ebay sales by 50% and managed replenishment of inventory for the ware house. Managed all shipping and receiving operations providing direction to staff.
2006 - 2009 Siemens Healthcare Diagnostics, Los Angeles, CA
RIA Reagent and Calibrators/Controls Manager
Direct and coordinate all departmental production activities personally or through subordinate supervisory staff. Ensure planned production requirements are met. Provide technical assistance to resolve production issues. Coordinate special projects aimed at improving efficiency and product quality and reducing production costs. Interface with other departments, especially R + D on the scale up and production of new products. Develop and revise standard operational and working practices to ensure compliance with standards. Compile and maintain production trend data and metrics. Within 14 months of hire was given the responsibility of a second department to manage (RIA Reagents). Responsible for all aspects of material management for both departments.
Developed demand planning tool to forecast future builds in order to identify raw materials which needed qualifying and purchasing
Improved OTD by over 100% through identifying process deficiencies and improving communication.
Decreased raw material inventory by 40%
Improved GDP through metrics, training and coaching.
2002 – 2004 Trinity Biotech PLC, Bray, Ireland
Director of Hemostasis
Successfully lead the transfer of a 10 million dollar Hemostasis manufacturing operation from Ventura Ca to Bray Ireland. With in one year was given the additional responsibility of managing second Hemostasis acquisition on year later. In addition to manufacturing responsibilities, directed the QC function of these product lines. Direct reports consisted of 2 Production Managers, 2 QC Supervisors, and 40 Biochemists and Fill Technicians.
Planned, coordinated, and supervised set-up, installation, and validation of Manufacturing Processes, Filling Equipment, Freeze Driers, and QC Analyzers into Bray facility.
Lead the effort to secure a second source of critical anti-body produced in house to support growth.
Developed and trained staff in Hemostasis procedures. Completed quarterly reviews and annual performance appraisals for direct reports. Implemented and appraised professional development programs for Hemostasis team.
Member of several Site Objective Teams, including purchase of new filler/labeler, new freeze drier, and installation of central dispensary.
2000 – 2002 Biopool International, Ventura, CA
Manufacturing Manager
Supervised the compounding and filling of Hemostasis In Vitro Diagnostic products. Direct reports consisted of 5 Chemists and 4 Manufacturing Technicians. Manufactured products to specification for on-time in-full delivery, hired and trained employees, maintained equipment, and developed processes to support new product development.
Increased OTD by 30% by streamlining Mfg processes and removing non-value adding activities
Designed successful methods of compounding and dispensing of buffers used in the amplification of nucleic acids. Contributed in the development of processes used in manufacturing disposables for this testing.
Upon purchase of Biopool by Trinity Biotech, lead a multidisciplinary team for plant closure relating to manufacturing, including essential equipment and raw material transfer to Ireland.
1991 – 2000 Medical Analysis Systems Inc., Camarillo, CA
Production Supervisor
Supervised aseptic dispensing and kit packaging operations for In Vitro Diagnostic products. Direct reports consisted of 14 full-time and up to 20 temporary technicians. Trained employees and maintained production equipment in accordance to cGMP and ISO9001 requirements. Arranged schedules with related departments to maximize efficient utilization of manpower, equipment, and facilities to meet production requirements.
Increased efficiency by 50% and decreased department overtime expenditures by 30% through use of creative scheduling and resource management.
Generated a 100% increase in production output in a one year time frame with an associated increase in head count from 9 to 11 permanent employees.
Facilitated, instructed, and mentored the development of self directed work teams.
Received an innovation award for the development of a tooling which increased quality and reduced customer complaints.
Received an outstanding contribution awards in the areas of training and teamwork.
Education
California State University Channel Islands, BS Business Management 2017