Medical Devices Biopharmaceuticals Expert Witness

Background

With over 40 years of experience in the pharmaceutical industry, Expert 3410 brings a wealth of knowledge and insight to his clients. He has provided consultation services within the biopharmaceutical world including topics such as manufacturing, quality assurance and regulatory issues. His background includes extensive experience in technical management; coordination of external and internal manufacturing; quality control and process development in the biopharmaceutical, medical devices, and fine chemical industries. Throughout his career, Expert 3410 has worked for or been affiliated with major pharmaceutical companies. His past experience includes launching new products and managing drug product manufacturing for both sterile and non-sterile products. He has led sourcing projects for new or alternative sources of active pharmaceutical ingredients.

Education

• MBA, Business Administration, Avila University, 1986
• MS, Organic Chemistry, Fordham University, 1958
• BS, Chemistry, Manhattan College, 1954

Specialties

• Biopharmaceuticals
• Medical Devices
• Fine Chemicals
• Chemistry / Organic Chemistry

Professional Memberships

•  American Chemical Society 1959-Present

Patents

Available Upon Request

Work Experience

A Company
Sr. Consultant

Consultation services within the biopharmaceutical realm including manufacturing, quality assurance and regulatory issues.  Also provides expert witness testimony using significant, extensive experience in technical management and coordination of external and internal manufacturing, quality control, and process development in the biopharmaceutical, medical device, and fine chemical industries.

Avila University
Adjunct Professor, Consultant
Develop curriculum, design course content and instruct courses involving Management, Statistics, Quantitative Analysis, Organizational Development, Business Policy, International Finance, and Finance. Independently perform consulting in the biopharmaceutical realm on manufacturing, quality assurance, and regulatory issues.

Sanofi-Aventis Pharmaceuticals, Inc.   
External Manufacturing
Coordinated technical and logistical activities with global and North American suppliers (both outsourced and Aventis) for drug product manufacturing- (sterile and non-sterile). Responsible for launch of new products and line extensions.

New Product Integration
Managed new product launches; led sourcing projects for new or alternative sources of active pharmaceutical ingredients; representative on SmithKline Beecham Consumer HealthCare Partnership team; managed business relationship with Elan Corporation pic (Ireland) on Cardizem manufacturing.

Program Management
Investigated, assessed, and introduced new product programs into Kansas City Operations.  Coordinated with Dow Chemical Company on evaluation/development of new radiochemical entity for US and Europe.

Elan Operations Manager
Managed team of technical/professional specialists involved in manufacturing of controlled release cardiovascular drug products in Elan Corporation (Ireland) plant for North American market.

Plant Manager
Started up manufacturing operation for medical and in-vitro diagnostic devices; managed compounding department for pharmaceutical liquids, creams, and ointments. Recruited, trained, and managed technical professionals, and 100 + hourly associates.

Diatom, Inc.
Plant Manager
Started up and managed complex vitamin synthesis plant. Recruited, trained, and managed professional/technical, non-exempt clerical and hourly workers in union environment. Roles included production, quality, maintenance, and scheduling.

Pfizer, Inc.
Quality Control Manager, Agricultural Division
Managed quality assurance of animal health products. Design and start up of quality operations. Managed professional/technical and laboratory technicians.

Manager, Chemical Products Control and Release:
Managed quality operations for synthesis and formulation of vitamins and fine chemical products.

Senior Supervisor Groton, CT Plant: 
Managed chemical  and microbiological testing activities in 4 QC laboratories staffed by professional scientists and laboratory technicians for bulk pharmaceuticals and antibiotics, fine chemicals, and vitamins.

Chemist, Process Control and Development:
Developed processes for manufacture and in-process control of active pharmaceutical ingredients, vitamins, and fine chemicals. Supervised scientist and laboratory technicians.

Proctor and Gamble Company
Products Research Chemist
Conducted applied research on role of oxidation of fatty acids in soaps. Developed methods to measure and prevent off-odors and rancidity.

Military Experience

United States Air Force
Commissioned Officer
Served on active duty as commissioned officer in Military Schools, Air Training Command. Discharged honorably from Reserve with rank of Captain.