API Synthesis, CRO Management and New Business Development Consultant for the Pharmaceutical Industry

Expertise

• Research, development and manufacturing of active pharmaceutical ingredients (API).
• Operation of contract manufacturing organizations (CMO) serving the pharmaceutical industry.
• Start up of new business in the global pharmaceutical, biotech and healthcare industries.
• Experienced with pharmaceutical compliance issues related to health, safety, environment and quality regulations.
• Senior management positions with record of business unit revenue growth rates of 30% - 75% while controlling the cost base.
• Driver of continuous improvement, major change programs, mergers and acquisitions, inward/outward technology transfer, new product registration, commercial manufacture and implementation of major IT programs for business improvement.
• Implemented new concepts in the design of facilities for high containment pharmaceuticals.

Experience

Independent Consultant, 2007 - Present

• API process and research and development.
• Safe handling of highly potent compounds.
• Occupational hygiene and health monitoring.
• New process scale-up.
• Process hazard assessment.
• Environmental compliance.
• cGMP standards.
• Clinical supply to phases I, II and III and commercial manufacture.
• Supply of materials from custom synthesis sources (GMP or non-GMP).

Almac Sciences, Craigavon, Ireland, Vice President of Technical Operations, 2002 - 2007

• For CMO company, strategic development and performance of the GMP Manufacturing Business Unit.
• Full P&L responsibility for the Business Unit.
• Responsible for all aspects of process research and development.
• Responsible for quality control, plant and process validation, maintenance, HSE, clean room standards, scheduling, logistics and 24 hour per day manufacturing.
• Negotiated and approved new business proposals and contracts.
• Designed, commissioned and validated specialized manufacturing facilities for highly potent APIs substances.
• Compliance with ISO14001, Integrated Pollution Prevention and Control, Good Manufacturing Practice and Health and Safety Regulations.
• Introduced new process hazard assessment techniques.

Oxford Asymmetry, Oxfordshire, England, Head of Process Development and Plant Operations, 1997 - 2002

• At a CRO had responsibility for process development and GMP manufacturing operations.
• Oversaw the design, construction, commissioning qualification and validation of an $18 million pharmaceutical manufacturing plant.
• Implemented ISO14001 accreditation and Integrated Pollution Control compliance.
• Participated in successful audits by the FDA, HSE and EPA.
• Implemented Enterprise Resource and Planning IT tools for data analysis.

Hickson PharmaChem, Cork, Ireland, Technical Manager, 1986 - 1997

• At a pharmaceutical contract manufacture organization, responsible for all aspects of technical support for 2 full scale pharmaceutical contract manufacturing plants.
• Year on year continuous improvement projects as part of customer service to constantly lower the cost of goods and optimize asset utilization.
• Participated in successful FDA , ISO and NSAI audits.
• ISO9001 and ISO14001 accreditation.
• Introduced statistical techniques for production monitoring and optimization, computerized process simulation and semi-continuous processing technology.

Arran Chemical Co., Galway, Ireland, Research and Development Manage, 1985 - 1986

• At a specialty chemical manufacturer, responsible for a small R&D team designing chemical processes for manufacturing and supplying customer samples.

Honors & Publications

Academic and Professional Affiliations

• Chartered Chemist and Fellow of the Royal Society of Chemistry.

Education

• Ph.D. Synthetic Organic Chemistry, Queen's University of Belfast, Ireland
• B.Sc. Chemistry, Award winning first class honors, Queen's University of Belfast, Ireland