Pharmaceutical Consultant: Formulation and Development of Dosage Forms

Technical Consultant #1569

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.

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.

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