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Pharmaceutical Consultant: Formulation and Development of Dosage Forms

Technical Consultant #1569


Expertise

  • Formulation and process development of multiple types of pharmaceutical dosage forms.
  • Research and development, optimization, manufacturing and packaging of solid, liquid and powdered dosage forms.
  • Scale up and technology transfer of multiple dosage forms.
  • Equipment and processing knowledge, product processing/equipment trouble-shooting and facility validation and qualification activities.
  • Identifying and implementing significant operational cost savings in pharmaceutical operations.
  • Auditing of diverse cGXP operations (API manufacture, laboratory operations, clinical dosage operations, CRO, medical devise manufacture).
  • cGMP, SPC, TQM, MRP II and DOE applications in development of optimal products and processes which are cGMP compliant and cost effective.

Experience

Undisclosed Company, President and Pharmaceutical Consultant, 2002 - Present

  • Formulations and process development of multiple dosage forms.
  • Scale-up and technology transfer of multiple dosage forms.
  • Set-up and optimization of both clinical and commercial manufacturing and packaging operations.
  • Assessment of client operations, identification and implementation of significant cost savings.
  • Equipment, process and facility validation and qualification activities.
  • Auditing of diverse cGXP operations (API manufacturing, laboratory operations, clinical dosage operations, commercial dosage operations, CROs, medical device manufacturers).
  • Advised on matters related to technology transfer, operations set-up, optimization and qualification, facility and process engineering services.
  • Assessment of contract service providers' capabilities (technical and quality systems) and their ability to fulfill a client's particular requirements.

Genaera Corporation, Assistant Director of Manufacturing, 2001 - 2002

  • Responsible for managing the formulation and process development, technology transfer and manufacture and packaging of the company's parenteral and solid-dosage clinical compounds.
  • Assessment equipment, facilities, systems, management and quality programs.
  • Advised on facility and quality related issues.
  • Participated in the preparation of regulatory filings with the FDA.

ProClinical Pharmaceutical Services, Plant Manager, 2000 - 2001

  • Daily management of production, warehousing, planning, maintenance, engineering and safety departments.
  • Plant involved in the formulation, manufacturing and packaging of clinical supplies for multiple companies.
  • Participated in client project development activities and client quality audits.
  • Routinely involved in facility management issues and the specification, acquisition, and qualification of plant equipment systems.

Atlantic Pharmaceutical Services, Manager of Technical Services, 1998 - 1999

  • Managed all technical project related to the development, scale-up, technology transfer and validation of client solid dosage products.
  • Managed the continued technical support of contract manufactured products.
  • Processed managed included spray drying, granulating, micro-encapsulation, extrusion, spheronization, milling, blending, tableting, coating, printing and encapsulation.
  • Extensive involvement with clinical batch manufacturing, multiple product launches and FDA PAIs.
  • Responsible for the development and management of a departmental operating budget and advising on the company's annual capital budget.

Colorcon, Micron Technologies Division, 1992 - 1998

Operations Manager, 1995 - 1998

  • Managed facility and equipment requirements, facility layout and design, and cGMP qualification of 33,000 sq.ft. facility, housing both contract micronizing and analytical laboratory operations.
  • Company spokesperson with the FDA and other local, state, and federal agencies on corporate issues.
  • Responsible for development and implementation of all production activities programs, such as quality, training, maintenance, calibration, safety, security and waste disposal.
  • Directed plant IOPQ and validation activities.

Manager Pharmaceutical Applications Development, 1992 - 1995

  • Managed company and client research and development studies to find new and proprietary applications for Colorcon excipients and functional coating systems.
  • Served as technical resource to clients on formulation and manufacturing practices.
  • Conducted studies to optimize processes resulting in significant cost savings and quality improvements.
  • Instructor for Colorcon's industry training seminar, "The Coating School."

ICI Pharmaceuticals, 1987 - 1992

Manufacturing Supervisor, 1989 - 1992

  • Complete responsibility of all shift-manufacturing activities.
  • Managed the activities of over 25 operators employed in cGMP, state-of-the-art processing with more than $200 million worth of solid and liquid dosage products.
  • Trained personnel in cGMP, SPC, TQM, and MRP II.
  • Identified operational cost savings in excess of $700,000.

Manufacturing / Packaging Process Engineer, 1987 - 1989

  • Development, scale-up, optimization and validation of solid and liquid dosage manufacturing and packaging processes.
  • Created necessary SOPs to ensure cGMP operational compliance.
  • Conducted studies to define equipment performance specifications for the purpose of equipment acquisition.

Wyeth Laboratories, Research Assistant, 1985 - 1987

  • Performed trials to optimize drug product formulations and processes for the company's solid, liquid and powder dosage forms.
  • Scale-up, transfer and validated these formulations and processes into cost-effective manufacturing operations, projects included working with steroids and antibiotic compounds.

Honors & Publications


Credentials

  • Certificate: Six Sigma Green and Black Belt / Statistical Process Control: Villanova University, PA
  • Certificate Occupational Safety & Health Administration Training: Delaware Technical College
  • Industrial Engineering (High Honors): Delaware Technical College

Education

  • MBA Global Management, University of Phoenix, Phoenix, AZ
  • B.A. Geology, University of Pittsburgh, Pittsburgh, PA
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