Kenneth D. Brown

• Communicated with managers of other departments to maintain transparency.
• Kept employee workloads fair and balanced to achieve objectives while maintaining high job satisfaction.
• Developed empowering employee culture focused on equipping employees to independently meet customer needs.
• Streamlined packaging processes by contributing in 3P kaizens
• Oversaw daily operational performance of Packaging team.
• Oversaw employee performance, corrected problems and increased efficiency to maintain productivity targets.
• Traveled to California to Participate in 3P kaizen to design new gummy packaging lines in new facility ($2,000,000.00 project)
• Assists with OQ, PQ trials to qualify new packaging equipment

• Performing direct manufacturing operations activities inside of manufacturing CAE
• Assists in expediting priority product and tasks in assigned areas
• Complies with U.S. Food and Drug Administration regulations, other regulatory requirements, company policy, operating procedures, processes, and task assignments
• Maintains cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Coordinates communication of work instructions to personnel in designated areas in accordance with supervisory directives

• Collected production samples regularly and performed detailed quality inspections
• Monitored staff organization and suggested improvements to daily functionality
• Sampled and analyzed raw materials, in process goods, and finished goods to assure compliance to specifications
• Ensured that new and revised SOPs and continuous improvement efforts are communicated and implemented
• Assisted in performing quality document activities including, but not limited to, issuing master manufacturing records, review and approving batch records and work instructions, ensuring logs, and records are appropriately completed and maintained, reviewing and approving shipping documentation, and filling and maintaining required as required
• Investigating customer complaints
• Conducting internal and external audits
• Partnered with operations team to build strong food safety culture, to ensure pre-requite programs are effective for producing safe food/supplement products

• Supervised MFG OPS associates and ensured that all personnel were trained to support the operations, planning, and execution of daily processes
• Assisted in the development and maintenance of capacity planning models and long-range production schedules
• Liaise with Document Control to create or revise, equipment logbooks, Standard Operation Procedures, Batch Records, and Protocols
• Manages of employee attendance and production records
• Observes and addresses performance and personnel issues
• Provides daily supervision of operations to develop and maintain final product schedules in support of clinical and commercial manufacturing
• Performed weekly checks in the Learning Management System to ensure that associates remained proficient on the current proficiencies
• Performed monthly process audits along with QA to ensure that mfg processing adhered to the standard operating procedures and the batch record
• Packaged and shipped final products as needed
• Supported department objectives and oversaw successful protocol rollout of three cost saving projects (Charter Medical Bag, Technoflex Cell Culture, Universal Waste Bag)
• Created aseptic audit template to be used for coaching and development of manufacturing associates
• Coached and Mentored underperforming associates to help develop their skillset
• Conducted Gemba Walks during internal audits to provide an overview of the manufacturing operations process
• Successfully executed validation runs to establish clinical production for early stage prostate cancer
• Successfully executed clinical compatibility studies for PROVENT
• Performed IQ/OQ and PQ's to ensure that new equipment is ready for use and continue to operate as expected
• Performed cycle counts to ensure that material quantity is consistent with production needs
• Established solid working relationships with peers, managers and directors through effective communication, organize work and leadership skills
• Increased safety awareness by 80%, which led to no injuries on team since 2017
• Determined efficient work schedules for team on weekly basis to keep project moving and each shift properly staffed
• Trained newly hired employees in aseptic processing and created training manual for all new hires to use as reference guide

• Ensure the proper set-up and operation of standard pharmaceutical process equipment such as Granulators, Blenders, Mills, Tablet Presses, Tablet Coaters and Packaging
• Ensures proper execution of Master Batch Records, standard operating procedures and validation protocols
• Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP's)
• Operate Vector Tablet Coating Machines
• Perform in-process sample/quality test
• Document analytical data per Master Batch Record
• Ensure accurate completion of equipment log and/or lab notebooks
• Interfaces and consult with Analytical Sciences and Quality Assurance personnel
• Recorded production data in daily logs

• Sequenced material for the Kia Sorento, Kia Optima, and Hyundai Santa Fe
• Providing on the floor leadership
• Supervising warehouse activities to ensure that JIT standards are met to provide necessary materials to support the manufacture of the Sorento, Optima, and Santa Fe
• Ensures that warehouse maintains 5-S manufacturing standards
• Providing failure assessments in the event that the production line at Kia should halt as a result of materials not being picked and loaded within a timely matter
• Complied with all standards and protocol requirements regarding warehouse operations, shipping and receiving and material handling
• Identified production problems through careful assessment of quality control system deficiencies
• Provided information to shipping and receiving personnel regarding inventory stock
• Supervised 20 employees in receipt and storage of automotive products

• Supervised MFG OPS associates and ensured that all personnel were trained to support the operations, planning, and execution of daily processes
• Assisted in the development and maintenance of capacity planning models and long-range production schedules
• Liaise with Document Control to create or revise equipment logbooks, Standard Operation Procedures, Batch Records and Protocols
• Management of employee attendance and production records
• Observed and addressed performance and personnel issues
• Provides daily supervision of operations to develop and maintain final product schedules in support of clinical and commercial manufacturing
• Monitored exceptions from initiation to closure to ensure proper turnaround
• Evaluated Corrective Actions/Preventive Actions (CAPAs) for effectiveness
• Performed weekly checks in the LMS to ensure that associates remained proficient on the current proficiencies
• Coordinated monthly/quarterly cleaning of production equipment
• Packaged and shipped final products as needed
• Adjusted warehouse inventory quantities in Oracle to reflect updates
• Executed new training initiative to improve skills and develop leaders from within
• Addressed employee and production issues to determine and implement optimal resolutions, preventing wasted resources and maintaining schedules
• Directed and motivated team of 50 manufacturing associates in pharmaceutical manufacturing setting
• Realigned workflows with changing business demands by evaluating processes and employee strengths
• Identified and corrected performance and personnel issues negatively impacting team and business operations
• Monitored employee performance and safety, conducting retraining to correct problems and optimize productivity
• Coordinated with internal departments to maximize operational efficiency across production and administrative areas
• Assessed employees' strengths and delegated tasks based upon expertise and knowledge, which increased workflows by 10%

• Responsible for aseptic manufacturing and assembly of clinical and commercial human derived components in a clean-room environment (class 10,000/ISO7 and 100,000/ISO8).
• Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Helps in validating processes and equipment that are directly related to filtration, cleaning and sterilization.
• Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.
• Executed corrective actions and develops innovative ideas for process improvement.
• Trained new team members, mentored Manufacturing Associates and set example as team leader.
• Was responsible for direct manufacturing oversight in the absence of the shift supervisor.
• Collaborated with departments in cross-functional teams, projects and GXP-related problem resolution and troubleshooting.
• Reviewed batch records to ensure that no deviations occurred during clinical and commercial processes.

• Involved in the interview process for district new hires.
• Supervise mobile blood drives and manage staff accordingly to produce a positive and productive work environment.
• Promote top-level customer service.
• OJT Instructor- train incoming and/or incumbent staff on new procedures, techniques, or processes that ensure the safe collection of blood and blood products.
• Continuing Education Instructor- conduct additional classroom related training to employees on new implementations, and or addendums/ changes to our current policies and procedures.
• Red Cell Operator- Utilize a mobile collection system to collect red cells from donors.
• Red Cell Collections Trainer- Train employees in the overall process from a process overview, equipment setup, demonstration of process, safety, and live training.
• Ensured that staff completed their training by monitoring proficiencies in B.I.T.S.
• LMS system.
• Perform Annual Competency Assessments.
• Conduct Annual Performance Evaluations.