- Active pharmaceutical ingredient (API) manufacturing.
- Pilot plant design and development to make API products.
- Pharmaceutical manufacturing scale-up and process development.
- Pharmaceutical validation, regulatory compliance and training.
- High potency products and hazardous reagents.
- International experience in API and specialty chemical manufacturing.
- Process start up and research and development.
- Process Safety.
- Software System Integration.
- Enterprise resource planning (ERP).
Undisclosed Company, Manager of Operations, 2006 - Present
- Venture start-up of red, green and blue phosphor production and development for LED illumination.
- Established initial commercial scale production, designed equipment, wrote SOPs and trained staff to run process.
Rhodia Pharma Solutions, Pilot Plant Manager, Deepwater, NJ, 2004 - 2006
- Project management of contract pilot scale, FDA approved manufacturing for API and intermediates, including clean isolation and handling.
- Commissioned all cGMP capacity with scheduled equipment qualification and training.
- Negotiated operational projects with potential clients.
- Followed up and resolved scale-up and process difficulties to meet delivery targets.
- Installed and ran over 50 projects in plant and kilo labs over 18 months with full cGMP compliance, including Phase I, II & III projects.
Merck & Co. Inc., Rahway, NJ, Project Scientist, 1996 - 2003
- Managed IQ, OQ & PQ for process and equipment validation; led NDA annual reviews and updates.
- Solved impurity problem allowing scheduled launch of new formulation.
- Isolated new impurity in API and coordinated process trials to reduce impurity and drafted revised CMC.
- Installation and start-up of two new APIs including troubleshooting and full validation.
- Introduced product improvement cost calculator for P&L and capacity evaluation, company wide.
- Developed paperless process change control approval system, installed and trained users.
- Worked with remote sites on process management team and problem resolution.
Noramco of Delaware, Inc., (Division of Johnson & Johnson), Manager of Operations, 1988 - 1996
- Responsible for three production units making API for internal and generic sale.
- Presented manufacturing capability to potential customers and auditors.
- Initiated process validation at site.
- Planned and managed government opium processing contract.
- Coordinated introduction of three new processes with piloting and the initiation of concurrent multi-process manufacturing.
- Sourced materials and managed contract for fast pace pilot campaigns.
- Led multi-disciplinary, multi-site team to select and install first division wide ERP system.
- QC Manager and led participant in FDA inspections.
- Amended, reviewed and updated DMFs for all narcotic APIs for generic sale.
- Generated manufacturing cost savings through Statistically Based Continuous Improvement program, (of Six Sigma Process Control; demonstrated Green Belt capability).
SmithKline Chemicals, 1980 - 1988
- Shift Supervisor, USA and Sr. Development Chemist, U.K., Mexico, Bahamas, Brazil, USA.
Glaxo Laboratories, Greenford, U.K., 1976 - 1980
- Technical Operations at API site.
Honors & Publications
Academic and Professional Affiliations
- American Chemical Society
- Enterprise Resource Planning (MFG-Pro)
- TrackWise. JMP
- Spanish, Portuguese and French
- B.Sc. Chemistry, University of Lancaster, UK