- Forty years of pharmaceutical and biotech industry experience - Production and development environments.
- Validation (computerized systems, equipment, processes), pre-acquisition - due diligence, quality assurance, compliance, quality control, research and development, technology transfer and clinical operations.
- Small and large molecule and vaccines, (Flu, Anthrax, and Rabies).
- International and domestic experience and assignments, (Europe, China and India).
- Exit strategy development, tracking and adjustment.
- Working with small, medium and large firms, assisting and managing; start-ups, start-overs and providing individual consulting services, of well established organizations.
- Noted clients served: DuPont Pharmaceuticals, Ohmeda Pharmaceuticals, Searle Pharmaceuticals and Aventis Behring.
- Marketed product, research and development, pilot plant operations, (product formulation) and technology transfer.
- Liquids, emulsions and lyophilized products.
- Aseptically filled, terminally sterilized, formulations with preservative systems.
- Buffered and non-buffered formulations.
- Ampules, multi dose vials, single dose syringes (i.e. Hypak System).
- Two container purge/fill/purge (i.e. Cozzoli) and high speed lines (i.e. Strunck and Calumatic).
- Manual light inspection and automated equipment (i.e. Esai).
- Manual and high speed labeling.
- Manual and automated packaging lines.
- Sterile facility (and supporting micro lab) design, construction, start up, validation and operation.
- Equipment selection, FAT, Installation, start up, validation.
- SOP, work instruction and batch record development, implementation and training.
- Automated systems (general): Selection, implementation, validation, training and go-live assistance.
- Enterprise Resource and Planning (ERP - SAP) and SAS (Clinical Data Management) - System implementation, validation, training and utilization: Guided clients during the planning, implementation and go-live transition phases to assure that planning, logistics, data migration and quality management were enhanced.
- Quality / quality systems and compliance: Evaluation, enhancement and remediation.
Undisclosed Company, Founder, 2004 - Present
- Quality and compliance consulting.
- Consent decree auditing and remediation.
- SAP Implementation - Quality and compliance oversight.
- Sterile and solid dosage form manufacturing subject matter expert.
- Project team management: RFP development, proposal evaluation, partner and personnel selection, scheduling, cost estimates and containment, status reporting and presenting, deliverable assurance, SOP's and training - making it all happen.
- Compliance auditing: Conducting, reporting, evaluation for regulatory exposure potential, remediation planning and execution project management
- Quality systems: Evaluation of status, enhancement suggestions, planning and execution.
- Management substitution: Short and long term.
- AIP (Application Integrity Policy): Comprehensive data review to assure the integrity of data presented to the FDA, this included:
- Clinical data review.
- Evaluation of data management procedures and processes.
- Analytical data.
- Validation - methods, processes computerized systems.
- All records.
Clarkston Consulting, International Consultant and Project Management, 2002 - 2004
- SAP implementation with vaccines manufacturer - focus on quality management (in United States and United Kingdom).
- Focus on Clients who manufacture sterile products.
- Facilitated a very effective SAP implementation.
- Bridging the understanding gaps among SAP / automated system implementation consultants and client quality management, successful alignment of these groups.
KMI/Parexel Consulting, Senior Consultant, 2002
- Quality systems evaluation and implementation.
- Focus on clients who manufacture sterile products.
- Facilitated useful quality system evaluations from which effective remediation plans were developed.
- Capability to quickly understand company culture from quality management and business perspectives and then draw the client in to remediation planning that is intuitive to the majority/key players.
Aventis Behring, Marburg, Germany - Sr. Director, Quality Assurance and Compliance, 2001
- Remediation planning and preparation for FDA and EU regulatory agency inspections.
- FDA inspection host; successful in shaping employees thinking relative to perception of what the FDA is looking for during as inspection of a foreign manufacturer and risk assessment in alignment with the ethics of the pharmaceutical industry.
Duramed Pharmaceuticals, Cincinnati, OH, Vice President Quality Operations, 2001
- Generics and NDA.
- Staff of one hundred twenty QA, QC and compliance professionals.
- Managed preparation for and successful FDA, German MOH and DEA inspections.
- FDA Inspection Host.
- Guided management towards balance decision making with regards to potential product recalls.
- Articulating the facts in an objective and structured manner thereby facilitating appropriate decisions, actions and management of opinions.
Searle Pharmaceuticals, (Monsanto), Chicago, IL, Director, International Quality Assurance, 1997 - 2000
- Provided client with manufacturing expertise and FDA experience.
- Quality operations for strategic and regional operations in Europe.
- International support in: Germany, Italy, United Kingdom and Moscow and Russia.
- Managed preparation for successful FDA and other EU regulatory agency inspections.
- FDA Inspection Host.
- Implemented corporate quality systems into European pharmaceutical operations.
- Successful FDA inspections of sites that had minimal or no experience in managing foreign (U.S.) inspections.
- Effective organizational and teaching skills.
Ohmeda Pharmaceuticals, Liberty Corner, NJ, Associate Director Validation, 1991 - 1997
- Sterile manufacturing, (emulsions), API and biotech manufacturing process validation in Puerto Rico, the U.K, and other European locations.
- Subject matter expert during FDA and MCA inspections.
- Key input and presentation during PAI and pre PAI relations, complete with perseverance and good communication skills.
Fluor Daniel, Marlton, NJ - Validation Department Manager, 1990 - 1991
- Department initiation and development.
Eastman Pharmaceuticals and Sterling Drug, Great Valley, PA, 1988 - 1990
- Manager of Quality Assurance and Research and Development.
- Small molecule and biotech research operations including, Laboratory operations in the U.S. and the U.K.
- Clinical site selection, auditing and routine monitoring, working at numerous two sites: MD Anderson in Houston, TX and Royal Victoria Institute in the U.K.
- Motivated non-GMP lab operations to become acceptable to perform marketed product release testing.
Dupont Pharmaceuticals, (Endo Laboratories), Manager, 1972 - 1988
- Working in several locations: Garden City, NY, Wilmington, DE and Manati, Porto Rico.
- Manager sterile manufacturing operations and manager sterile pilot plant operations.
- Marketed sterile products manufacturing, sterile formulation development, technology transfer and formulation trouble-shooting.
- Solid dosage formulation.
- Packaging line supervisor.
- Quality assurance Supervisor.
- Key player during transfer of line of sterile products to new facility in Manati, PR.
Other Professional Activities
- U.S. Army
- B.S. Biology from Neumann College in Aston, PA