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

Technical Consultant #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).

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
Save Resume #1509
to Contact Form?

You must first click "Yes" to save this resume

Submit Request

You have no Saved Resumes

Add resumes within our various Ares of Expertise by clicking "Add Resume(s)" below.

Add Resume(s)