Quality Manufacturing

Peter Ercoli

Vice President Operations

Memphis, TN

**********@***.*** - 314-***-****

WORK EXPERIENCE

Vice President Operations

Oxford Immunotec Global PLC - 2012 to 2016

Led Global Lab and Manufacturing Operations to include all Supply Chain activities. Maintain site management of R&D, Technical Operations, Call Center activities, Quality Assurance and Quality Control.

- Reliably supplied 52 countries with product with a record of zero back-orders or product recalls

- Created the appropriate infrastructure, staff, processes and procedures to stabilize US lab operations

- Rapidly grew the business 30%-40% year on year for 3 years

- Increased profit margins 275% over the same period.

- Increased throughput by 500% while reducing labor rate of growth through efficiencies and process enhancements

- Established US manufacturing capability and capacity

- Created, integrated, and executed 5-year strategic plan in support of corporate growth objectives to diversify risk and expand capacity

VP Supply Chain/Operations

KV Pharmaceutical - 2011 to 2012

Sourced and developed relationships with all 3rd Party Manufacturing to ensure Quality, timely new Product Launches, robust Product Development, and reliable Supply Chain and Distribution operations.

- Successfully negotiated legacy Consent Decree to re-launch two new products.

- Coordinated the transition to 3rd Party Manufacturing after divesting brick and mortar manufacturing assets.

- Facilitated the construction and initiated the execution of a 5-year strategic plan General Manager

Eurand, Inc - 2007 to 2011

Directed Regulatory and Quality Compliance, R&D activities, scale-up and Manufacturing operations with significant positive impact to P&L

- Maintained a zero 483 audit status through all FDA audits

- Led site to stand alone profitability increasing product margins from -3% to over 35%

- Implemented Key Performance Indicators (KPIs) to track quality enhancements, microbiologic activities and Root Cause Analysis impact

- Instituted Continuous Improvement programs and initiated Lean and 6 Sigma initiatives to enhance quality and productivity

- Successfully executed $6MM capital project to expand R&D and Quality Control operations

- Post-acquisition project co-lead successfully integrating the Eurand and Axcan organizations into Aptalis Pharma

- Significant contributor to Curriculum Advisory Boards for Sinclair Community College and BioOhio's BioScience Curriculum focused on local growth of bioscience talent Group Plant Director

KV Pharmaceutical - 2006 to 2007

Led all manufacturing and packaging operations for solid and liquid pharmaceutical products to exceed Federal Regulatory and Quality Compliance standards.

- Maintained good standing with FDA throughout all facilities

- Primary Operations interface for all regulatory agencies

- Created overall production strategy to fully utilize all capital assets and optimize plant staffing resulting in backorder reductions of $3MM

- Implemented Sales & Operations Planning with the generic and branded marketing and scientific affairs groups to ensure appropriate responsiveness to exploit market opportunities, prepare for new product launches and meet overall customer needs

- Major contributor within a small executive team tasked to create, communicate and drive newly formed Division Strategy to enhance culture, customer focus and profitability

- Drove improved management-employee relations resulting in Union decertification. Plant Manager

KV Pharmaceutical - 2004 to 2006

Recruited and hired to revitalize struggling liquids and solids manufacturing and packaging production and quality operations in only unionized plant.

- Results included dramatic improvements to first pass quality record; safety records; FDA inspection results; while achieving new records and standards in production and efficiency

- Instilled a culture of enduring quality principals resulting in good standing with all regulatory agencies

- Instilled disciplined manufacturing practices reducing quality defects by 80%

- Restore roles and responsibilities and associated accountability building esprit de corps and cross-functional collaboration.

- Transitioned the struggling plant to a compliant, high performance, customer focus production unit Director

Solids Manufacturing, Boehringer Ingelheim Roxane Inc - 2001 to 2004 Selected to serve in Manufacturing role to address issues associated with FDA regulatory action

- Primary FDA Operations interface during extensive audits remedying observed quality issues

- Lead a brownfield transformation to Lean Manufacturing successfully introducing SMED, 5S, and JIT inventory control processes

- Optimized staffing levels to address substandard GMP practices

- Developed Manufacturing capabilities becoming international launch site for Generic and Branded products Associate Director

Boehringer Ingelheim Roxane Inc - 1998 to 2001

Created cross-functional operational teams focused on stabilizing quality operations while enhancing dynamic business systems within Liquid and Metered Dose Inhaler technologies.

- Established multi-disciplined business teams aimed at streamlining new product commercialization.

- Facilitated companywide strategic imperatives centered on regulatory compliance, innovative partnerships, leadership, and manufacturing excellence.

Business Analyst, SAP Implementation Team, Roche Diagnostics (Boehringer Mannheim), (1998)

- Created manufacturing based training programs to familiarize and integrate existing shop floor control personnel, corporate wide, with standardized SAP workflow.

- Successfully launched full SAP capabilities with no impact to day-to-day operations Production Manager

Boehringer Mannheim Corporation - 1997 to 1997

Implemented work cells better utilizing formal and informal leadership to control the quality systems that defined the manufacturing process.

- Created a supervisory sustainment program to create a check and balance quality system. Operations Analyst

Boehringer Mannheim Corporation - 1996 to 1997

Defined and directed the implementation of material flow Pull System in manufacturing reducing Work in Process inventories by 60%.

- Implemented KANBAN system reducing manufacturing cycle time by 87%.

- Developed cost strategy to identify and prioritize quality losses, logistics, engineering and manufacturing initiatives resulting in a 26% reduction in COGS.

- Developed and integrated automated Batch History Records to eliminate redundant document audits. Operations Supervisor

Boehringer Mannheim Corporation - 1994 to 1996

Implemented, maintained and assisted in the development of a Quality Assurance program to satisfy both FDA and ISO 9000 certification requirements.

- Increased process efficiencies from 50% to 95% through employee focus teams.

- Consulted and approved the development of re-engineered manufacturing processes. Superintendent

The Youngstown Welding & Engineering Co - 1992 to 1994 Motivated, trained, and inspired multi-disciplined union manufacturing group.

- Decreased workmanship defects from 28% to less than 1%

- Increased productivity from 65% to 92% through employee quality consciousness programs

- Directed operational budgets and capital expenditures to upgrade equipment, reduce bottlenecks and improve safety

Captain

United States Army - 1987 to 1992

Provided leadership, training and motivation to multi-level work force to develop highly proficient work teams under extremely stressful conditions.

- Established a train the trainer program to maximize the education and experience of first line supervisors. EDUCATION

Crosby Quality College

2002

BS in Systems Management

U.S. Military Academy - West Point, NY

1987

MILITARY SERVICE

Service Country: US

Branch: Army

Rank: Captain

May 1987 to September 1992

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