Pharmaceutical compounding, filling, packaging, validation, warehousing, business

Pharmaceutical Compounding, Filling, Packaging, Validation and Business Consultant (1042)

Expert in filling and packaging of pharmaceutical products.
Vaccine filling and packaging consultant.
Operations management and leadership experience in all aspects of bulk manufacturing, aseptic/solid dose filling/packaging, sterile formulation, validation, contract manufacturing and new business development.
GMPs, CFR as they pertain to the manufacture of biological and pharmaceutical products.
Interactions with personnel at the FDA, USDA and DEA.
Experience with organizational renewal, formulating policies and procedures, implementation and maintenance of quality systems, corporate planning and expansion, operations evaluation, packaging development, packaging engineering, budget design and control, cost reduction, new capital acquisition, project management, warehousing, scheduling, quality assurance and process control, government regulatory compliance, production supervision, new product start-up and union negotiation.

2000 – Present Independent Consultant

A pharmaceutical filling and packaging consulting organization serving clients in devices, pharmaceuticals, biotechnology and the government.
Evaluate client needs, develop and provide proposals, implement client approved recommendations, and market services.
Provide compliance oversight for organizations with FDA issues.
Plan and conducted quality system audits and due diligence audits.
Identified contract sterile filling facilities, conducted audits, prepared contracts and technical addendum's and concluded agreements within two months to meet client requirements.
Identified device manufacturing and assembly contractors and conducted due diligence audits for clients.
Assisted client in obtaining product license approval.

1988 - 2000 Aventis Pasteur, Swiftwater, PA

Director of Filling and Packaging Projects (1999-2000): Responsible for coordinating, planning, budgeting, and managing local and global Filling and Packaging projects to meet corporate goals and strategic plans.
Managed 150 permanent employees and 50 seasonal employees in sterile compounding, filling, packaging (development/engineering/maintenance), product distribution, warehousing, and printing operations. Also responsible for coordinating, planning, budgeting, assessing new products, technologies, materials.
Manager of Filling and Packaging (1988-1990): Responsible for managing, coaching, and directing 60 permanent employees and 50 seasonal employees in sterile compounding, filling, packaging (development/engineering), and printing operations with four reporting Supervisors.

1985 – 1988 Zenith Laboratories, Northvale, NJ (Now part of Tevo Pharmaceuticals)

The company produces generic solid dose pharmaceuticals.
Director of Pharmaceutical Packaging: Managed 150 employees on multiple shifts in label purchasing, tablet and capsule filling, packaging, maintenance, warehousing, packaging development and engineering.

1973 - 1985 Hoffmann-LA Roche, Nutley, NJ

The company manufactures ethical solid dose and parenteral pharmaceuticals. They are also involved with diagnostics, chemicals and animal health. A
Production Supervisor, Roche Diagnostic Systems Division (1977-1985): Managed bulk manufacturing, sterile filling and packaging.
Assistant Scientist (1973-1977): Executed research and development experimental protocols on basic nutrition research.