API Synthesis, CRO Management and New Business Development Consultant for the Pharmaceutical Industry (1509)
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).
- 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.
- 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.
- 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.
- 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