Pharmaceutical Manufacturing Consultant: API, Specialty Chemicals, Pilot Plant and Regulatory Compliance

Technical Consultant #1532


Expertise

  • 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).

Experience

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

Certifications

  • Enterprise Resource Planning (MFG-Pro)
  • LIMS
  • TrackWise. JMP

Languages

  • Spanish, Portuguese and French

Education

  • B.Sc. Chemistry, University of Lancaster, UK
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