Michael Harris Email & Phone Number

Baltimore, Maryland, United States

Baltimore, Maryland

Lead Polymer Manufacturing, Packaging and Labeling Operations, Shipping and Receiving, and EHS.

Baltimore, Maryland

Manage Polymer Manufacturing and Process Engineering.

Head of Manufacturing overseeing the manufacturing operations of products and finish goods inventory. Direct the development of the point of care system reagents and the lyophilization of assay reagents. Manage product transfer from development to manufacturing.

• Successfully completed a six month contract with Roche Diagnostics to complete an international transfer of manufacturing operations for 37 products from the United States to two facilities in Germany.
• Designed the floor plan and process flow for the designated production space at Roche Diagnostics.
• Advised Roche Diagnostics on resource requirements, production planning, supply chain management, facility requirements, and preventative maintenance programs.
• Developed training plan for the product transfer. Executed plan to train management and personnel on all aspects of production planning and execution.
• Assisted with the initial setup of the production area, startup of production equipment, and the production of product.

• FDA cleared for medical devices and an ISO 9001 certified company that develops and manufactures biological and chemical detection systems for the BioDefense and Life Science diagnostic markets using proprietary ECL.
• Directed all aspects for the manufacturing of 49 BioVeris catalogued products and 51 contract manufactured products consisting of lyophilized detection kits and system reagents utilized by the ECL Detection Systems.
• BioVeris Manufacturing representative for the Roche Acquisition, Roche Transition Team, Quality and Financial Audits, and Project Core Teams.
• Implemented site shutdown plans for Manufacturing that included increasing inventory levels, staff reductions, disposal of raw materials, equipment/facility shutdown, and arranging equipment shipments to Germany.
• Inspired staff’s motivation, commitment, and professionalism during the facility shutdown.
• Instrumental in contract negotiations with the U.S. Department of Defense’s Critical Reagents Program (CRP) on behalf of Roche. Advised the Department of Defense (DoD) and Roche on process capabilities, specifications.

• North American Vaccine develops and manufactures vaccines for the prevention of human infectious diseases.
• Member of the Fermentation Department that inoculated, fermented, and harvested Bordetella pertussis for the use in manufacturing of DTaP vaccine, Certivâ.
• Revised and reviewed Production Methods and SOPs according to cGMPs.
• Worked with the company in obtaining FDA licensure of the DTaP vaccine, Certivâ, by assuring that the manufacturing documents and laboratories were in compliance with cGMPs for FDA.

Bs, Biology

Six Sigma Black Belt, August 2008