Manufacturing Professional Experience
Resume:
Kevin J. Morse
**** ********** **, *****, ** ****4
*************@***.***, Phone 847-***-****
Qualification Summary
Extensive technical knowledge of pharmaceutical processes and regulations requirements in both lab and quality settings.
Strengths in pharmacology, animal techniques, and cost improvement initiatives in a highly regulated laboratory environment.
Experience in providing structured on the job training.
Development of Pharmacology studies in the area of drug metabolism.
Professional Experience
Abbott Laboratories, Diagnostic Division,
Advanced Manufacturing Specialist, September 2007 to February 2013
Management and completion of manufacturing work orders to support the production schedules and maintain inventory levels to supply the global demand of Rare Reagent test kits. Established inventory levels and reordering signals for components and disposable materials that supported multiple product lines. Completion of component level inspections and determination of accept/reject on incoming component lots. Investigation of testing failures and documenting results within approved quality management systems.
Extensive knowledge of pharmaceutical laboratory practices in tissue culture, antibody purification, chromatography, conjugation techniques, and micro particle coating.
Subject Matter Expert for chromatography troubleshooting and technical expertise.
Performing receiving and inspection activities for components used in manufacturing processes.
Environmental monitoring activities of biological labs, clean rooms, and sterile filling operation areas.
Abbott Laboratories, Global Pharmaceutical Research and Development Division, In Vivo Associate Pharmacologist, June 2006 to September 2007
Development, execution, and final report completion of pharmacologic studies utilizing various animal species under the guidance of Sr. PhD’s in the Global Pharmaceutical Research and Development Division.
Technical expert on dosage routes and surgical techniques for various animal species.
Authored standards for the development of resources (live animals) needed, materials needed, as well as the identification of departmental support for various protocols involving vivo and in vivo techniques.
Driver of continuous improvement by searching for and implementing new techniques for improved efficiency.
Development of technical protocols to support the ongoing studies of Sr. PhD’s within the department.
Abbott Laboratories, Diagnostic Division
Manufacturing Prep Technician I, 1988- June 2006
Management and completion of manufacturing work orders to support the production schedules and maintain inventory levels to supply the global demand of Rare Reagent test kits. Established inventory levels and reordering signals for components and disposable materials that supported multiple product lines. Partnered with Third Party Suppliers to ensure the inventory needs for live animals for the Rare Reagents Business Unit were maintained. Authored nonconformance exception reports as required per quality system requirements. Authored and executed process change controls to continuously improve manufacturing processes to ensure compliance with business unit requirements. Performed investigation to determine the root cause of failures discovered during downstream testing.
Identified and implemented cost reductions in the Polyclonal antibody production area that resulted in substantial savings to the company each year.
Produced Ascites fluid in mice, using multiple monoclonal antibody clones under current IACUC (Institutional Animal Care and Use Committee) and AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) guidelines to meet critical production needs.
Completed investigational preps using pre-approved manufacturing protocols written by technical product development in order to find root cause issues in various products.
Demonstrated manufacturing preps to for FDA auditors during critical audit situations.
Subject matter expert for all polyclonal and monoclonal antibody production activities.
Best demonstrated practices in Animal handling: mice, rats, rabbits, guinea pigs, goats, sheep, dogs
Licensed Certified Drug Agent (CDA) for materials used in manufacturing work orders.
Creation of Structured On-the-Job Training modules for contractor use/training for polyclonal antibody production area.
Development of training and skill competency assessments of new employees in the area.
Abbott Laboratories, Diagnostic Division
Manufacturing Prep Technician II, 1986-1988
Completed the manufacture and purification of HTLV I/II and HIV viruses using tissue culture techniques, polyclonal antibody production, and Mouse Ascites production. Completed production and material schedules to build and maintain inventory to supply the global demand of Rare Reagent test kits.
Performed the seeding, harvesting, and purification of HIV tissue culture.
Education
B.A, South Dakota Wesleyan University, Mitchell, South Dakota, 1986
Major: Business Administration
Awards
Vice President Award, 2003-Maintained HIV Ag-rabbit pools in the factory
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