Kevin Cole, Mmc Email & Phone Number

Silver Spring, Maryland, United States

• Define, plan, and execute small scale site projects at Silver Spring facilities and remote sites as directed• Provide Silver Spring and remote site asset management, including new asset and operations activity management• Lead Silver Spring and remote site BMRAM and ADEPT administration• Support troubleshooting complex mechanical and automated equipment issues to ensure optimal functionality while adhering to cGMPs• Manage writing/completing equipment SOPs, change controls and deviations for GxP engineering and facilities operations• Effectively communicate technical issues with equipment vendors and supporting departments during troubleshooting activities and maintenance/repair visits• Support ongoing validation efforts for production area equipment and processes• Develop management system/process for end user BMRAM support

Silver Spring, Md

• Manage engineering staff and activities. Primarily the annual preventative maintenance schedule for all GMP and utility equipment for the Fill / Finish and Biologics manufacturing areas utilizing the Blue Mountain RAM system • Manage on demand equipment repairs and replacement of all GMP equipment. GMP Equipment includes but is not limited to, Groninger filling line with Skan Isolator, Rommelag BFS, Autoclaves, Washers, Pall and Millipore Chromatography skids and Millipore TFF skids• Manage the support of ongoing validation efforts for all GMP Fill/Finish and Biologic equipment and processes• Oversea annual HEPA integrity testing as well as area balancing in all GMP areas through vendor contracts• Troubleshoot complex, mechanical and automated equipment issues in Fill/Finish and Biologic area to ensure optimal functionality while adhering to cGMPs• Manage all GMP service contracts and all spare parts orders for both the Fill / Finish and Biologics areas• Manage the revision and creation of department SOPs, change controls and deviations using Trackwise Digital and Master Control• Effectively communicate technical issues with equipment vendors and supporting departments during troubleshooting activities and maintenance/repair visits• Ensure the continuous, uninterrupted availability and functionality of Fill/Finish and Biologic manufacturing and utility equipment required to support GMP production campaigns

Frederick, Md

Supervise Upstream and Downstream manufacturing technicians. Manufacturing activities included but were not limited to, media prep, buffer prep, cell culture inoculation, bioreactors (100L to 15,000L), raw material dispensing, tank CIP & SIP and small scale stock solution prep.

Frederick, Md

Supervise downstream purification manufacturing technicians. Large scale column chromatography, UF/DF and Nanofiltration operations.

Frederick, Md

Perform all downstream processing operations, to include performance and monitoring of process steps, and protein purification/ separation techniques (e.g. membrane filtration, depth filtration, ultrafiltration and column chromatography) and cleaning and sanitization of equipment (CIP’s & SIP’s).; Act as the primary trainer of those with less experience; If necessary, act as an interim Supervisor; Generate SOP's, MPR's and validation protocols for equipment and procedures used in the manufacture of biological based products

Owings Mills, Md

Responsibilities: To plan and assign work daily to meet the production schedule; To ensure that all company policies as well as SOP’s, and cGMP’s are being followed; To check and review production batch records for accuracy during and after production; Write and respond to deviations and investigations as needed; Maintain employee personnel files tracking vacation, sick time and any company policy violations; Write and revise SOP’s and batch records; Perform disciplinary actions; Conduct performance appraisals.

Cincinnati, Oh

Formerly Duramed PharmaceuticalsResponsibilities: Manufacture solid dosage pharmaceuticals using PMA Granulators, Closed Cycle Utility Spray Dryers, Comills, Sieves, Sweco sifters, Screen calibration, Spheronizers, V- Blenders, and various sized Pony mixers.

Ft. Campbell, Ky

5th Special Forces Group (Airborne), Ft. Campbell, KY.Active Duty for 4 years. Responsibilities: Pack, inspect and repair various types of personnel and cargo parachutes for airborne operations.Served in multiple overseas deployments to various countries including but not limited to Kuwait (3x), Bahrain, U.A.E and Egypt throughout my time in the 5th Special Forces Group (Airborne).

Maintenance Manager Certification (Mmc), Maintenance Management

This program was designed for maintenance managers and professionals responsible for building and sustaining a world-class maintenance.

Planning And Scheduling Certification (Psc), Planning And Scheduling

This program was designed for professionals responsible for building and sustaining a world-class maintenance planning and scheduling.

Bachelor Of Science (B.S.), Business Administration, Graduated Cum Laude With A 3.85 Gpa

Activities and Societies: Phi Theta Kappa: International College Honor Society

Us Army, Ft. Campbell, Ky, Sling Loading And Helicopter Rappelling

Trained to conduct air mobile and air assault helicopter operations, to include aircraft orientation, sling load operations, proper.

Parachute Rigger (43E / 92R), Us Army, Ft. Lee, Va, Aerial Delivery And Field Services Department

Trained in the skills and knowledge to inspect, pack, rig, recover, store and maintain aerial delivery equipment.

Us Army, Ft. Benning, Ga

Basic paratrooper (military parachutist) training for the United States armed forces. The course is three weeks long and consists of three.

Us Army, Ft. Leonardwood, Mo

10-week training produces values-based, disciplined Soldiers, who are trained in basic skills, Warrior Tasks and Battle Drills..