Larry Servi Email & Phone Number

Leading Product and Process Development engineering services provided to the Pharmaceutical, Biotechnology & Medical Device Industries. * Directed a portfolio of programs, including staffing and oversight, that ensured customer satisfaction and led to significant repeat business: • Developed and implemented best-in-class Product Development Procedures • Led several successful Quality System Remediation programs including CAPA, Risk Management, Design Controls, Process Validation and Regulatory Analysis* Wrote case studies, authored articles on Risk Management and Design Controls, and spoke on Quality Systems at a national conference.* Implemented standardized project management in a multiple-platform consulting business.

As a senior manager in an R&D organization developing blood processing instrumentation and associated disposable products for a global $500 million business, was selected by Division Management to establish an Office of Project Management, chartered to improve the efficiency and predictability of product development. * Hired and deployed a team of talented project managers, and implemented improved project management practices. Predictability in meeting project milestones improved by over 30%. * Managed operations, including budget, performance metrics and resource deployment databases, for an organization of over 120 professionals. * Led an initiative to outsource manufacturing of three complex instrumentation product platforms. * Negotiated transition services to be provided by Baxter following the sale of the Fenwal business.

Directed global new product development and support for a $300 million business including drugs and devices used for blood collection, component separation, filtration and storage. * Jointly with Marketing, developed & implemented a strategy to reinvigorate a mature product line. * Commercialized 52 new drug and device products contributing over $60 million in annual sales. * Managed a joint development program with a Japanese firm for new filtration technology. * Launched an improved needle that reduced pain for 30 million donors annually.

Led Manufacturing Operations, Plant and Process Engineering, R&D and Facility Maintenance for Thermal Interface and EMI Shielding products used in telecommunication, automotive, and computer applications. * Championed development of revolutionary new processes designed to provide a leap in manufacturing efficiency and to eliminate the need for costly emission control upgrades. * Implemented a lean six sigma program across all manufacturing & materials handling processes. * Led new facility construction that tripled manufacturing floor space.

Directed product development for a $250 million Wound Care business while managing Process Development, Pilot Production, CAD & Mold Shop departments supporting a $3 billion business. * Shifted company strategy toward larger opportunities, changed department culture and achieved ISO & QSR compliance while launching over 60 new products with annual sales over $20 million. * Convinced the FDA to classify a new antimicrobial dressing as a device rather than a drug. Reversed the FDA’s initial ruling and put the project back on track. * Managed Manufacturing & QA operations for four product lines that doubled in volume each year. Implemented process and personnel upgrades that reduced cost and increased capacity by 40%.

Improved efficiency & productivity of Urology Product Development, the CAD Department and the Mold Shop. This was accomplished by hiring talented people, creative cross training, and investing in new technologies. * Introduced 96 new products over a five-year period contributing $15 million in annual revenue. Moved company from third to second market share position. * Championed new injection molding, moldmaking, and CAD solid modeling capabilities that shortened project completion time by up to 50%. * Took a tough position against a catheter design proposed by an autonomous manufacturing plant. Proposed an alternative that achieved virtually zero defects.

Round Lake, Il And Valencia, Ca

Positions of increasing responsibility, starting in the Corporate Polymer Development group in Round Lake, then moving into Product Development and eventually moving to the Pharmaseal Division after the merger with American Hospital Supply in 1985.Led medical device and drug container product developments in Urology, Gastroenterology, Radiology, Respiratory Care, and products for General Surgery

Masters, Engineering Management

Bachelor Of Science, Chemical Engineering

Activities and Societies: NU Marching Band Soccer Club

Education record