Manufacturing Engineer

Michael Cady

Email: *********@********.***

Address: **** ******** ****

City: Vadnais Heights

State: MN

Zip: 55127

Country: USA

Phone: 651-***-****

Skill Level: Director

Salary Range: $175,000

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Michael E. Cady 651-***-****

3770 Parkwood Lane *********@********.***

Vadnais Heights, MN 55127

SUMMARY:

I am a hands-on operations executive with the experience and know how to develop big picture strategic objectives and identify, evaluate and implement optimal plans and tactics with appropriate levels of detail. Success in achieving these objectives depended upon building cooperative, cross functional teams, establishing clear expectations and maintaining a balance of flexibility and consistency.

Core competencies include planning, contract development, regulatory interpretation and negotiation, financial modeling and evaluation, quality systems design, process evaluation and optimization, make vs. buy evaluations.

EXPERIENCE:

Biothera - Eagan, MN

Biotechnology company dedicated to improving immune health through the development of a natural gluco polysaccharide that engages and directs natural innate immune system responses. The company is commercializing this carbohydrate technology through two business groups:

Pharmaceutical Group - Biothera is developing a drug (Imprime PGG(R)) to work synergistically with anti-tumor monoclonal antibodies against colon, lung and other cancers.

Healthcare Group - Biothera manufactures and markets patented food-grade immune health ingredients for functional food, beverage, nutritional supplement, cosmetic and animal nutrition products worldwide.

Vice President, Operations 2004 - April 2012

Responsible for all Biothera Pharmaceutical and Healthcare Operations activities through the organization, staffing and leadership of Materials Management, Quality, Procurement, Manufacturing, and Engineering activities. This included:

* Development and execution of strategic and tactical plans and budgets ($10 million+ per year) to achieve overall company objectives

- Development of a simple MRP system that accurately forecasted bulk and retail product volumes and mix and established more precise re-order points enabling a significant reduction in inventory levels and working capital.

- Negotiated -just-in-time- delivery of bulk ingredient from major supplier

* Evaluation of new product concepts, technologies, and processes to determine feasibility and cost implications.

* Providing direction to process development and cost improvement activities

- Achieved 50% reduction in patented nutritional product manufacturing cost through implementation of new process and transfer to new manufacturer

* Interaction with US and EU regulatory authorities and ensuring regulatory compliance

* Evaluating internal vs. external manufacturing alternatives, and negotiating contracts and Quality Agreements

* Drafting, editing and organizing US and EU regulatory submissions

* Evaluation, selection and management of contract manufacturers

* Directing and executing tech transfer programs to enable contract manufacturing

- Completed seven fold scale - up of drug substance manufacturing resulting in ten fold reduction in manufacturing costs

- Reduced drug product manufacturing costs by 75% through change in manufacturer, increase in scale and process simplification

* Conducting due diligence on potential acquisitions resulting in one beneficial acquisition and rejection of two others due to unsustainable manufacturing methods

Assistant Vice President, Operations 2002 - 2004

Responsible for:

* Assisting in startup and management of Central American chitosan manufacturing facility

* Supervision of Manufacturing, Engineering and R&D staff

* Establishing quality systems for dietary/nutritional supplement operations and products

* Evaluation, organization and prioritization of purchased intellectual property enabling the company to significantly reduce the resources and time necessary to file its first IND.

* Evaluation of potential contract manufacturers

* Transferring drug manufacturing technology to small scale contract manufacturer

GalaGen, Inc - Arden Hills, MN

Biotechnology company involved in developing, commercializing, and manufacturing bovine dairy based immunoglobulin products for pharmaceutical and nutritional applications.

Co-founder, executive officer, and Vice President, Manufacturing and Engineering 1992 -2002

Responsible for:

* Represented manufacturing operations of company during selection of investment bankers and subsequent IPO

- Co-authored prospectus

- Successful IPO April 1996

* Organizing, staffing and leading Materials Management, Quality, Procurement, Engineering and Manufacturing

* Evaluation of new product concepts, technologies and processes to determine feasibility and cost implications

* Establishing resource requirements (outsourcing, facilities planning, staffing, budgeting, forecasting)

* Interaction with regulatory agencies including FDA Center for Biologics Evaluation and Research (CBER), FDA Center for Food Safety and Applied Nutrition (CFSAN), FDA Center for Veterinary Medicine (CVM), USDA Food Safety and Inspection Service (FSIS), USDA Animal and Plant Health and Inspection Service (APHIS) and the Minnesota Department of Agriculture.

- Presented unconventional plan for establishment license to FDA and obtained agreement

- Negotiated with and obtained approval from MN Dept. of Agriculture to implement alternative to pasteurization of food ingredient resulting in significant yield improvement

* Design, construction and operation of a small scale cGMP manufacturing facility

* Negotiated contracts to support internal manufacturing activities including procurement, analytical services, antigen manufacturing and final product packaging

Procor Technologies, Inc. - Arden Hills, MN

Procor was a subsidiary of Land O`Lakes, an agricultural cooperative, formed to commercialize drug products and dietary supplements utilizing milk derived bovine immunoglobulins.

Co-founder and Director of Operations 1987 - 1992

Responsible for:

* Evaluation of technology and development of initial business plan that substantiated funding of the venture

* Establishment of manufacturing supply chain

* Renovation of a manufacturing facility resulting in USDA biologics licensure

* Providing manufacturing, procurement and engineering capabilities that supported the development and commercialization of three USDA licensed biologics

* Reduction of manufacturing cost of major product by over 50% due to process optimization and procurement efficiencies

Land O`Lakes, Inc.

Foods/Cheese Operations - Planning Manager - Arden Hills, MN 1984 - 1987

Beef Division - Planning Manager - Arden Hills, MN 1982 - 1984

Poultry Division - Division Engineer - Albert Lea, MN 1979 - 1982

Swift and Company - Plant Industrial Engineer - Clinton, IA 1978 - 1979

Poultry processing

Dubuque Packing Company - Industrial Engineer -Dubuque, IA 1977 - 1978

Red meat slaughter and processing

EDUCATION:

* 1985 University of St. Thomas MBA with an emphasis in financial management

* 1977 University of Iowa BS Industrial Engineering with an emphasis in operations research

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