Kenneth Harris Jr.
Raleigh,NC
Summary
Manager of Aseptic /Non Aseptic Formulation, Media Formulation, Filling, Packaging , and Biotech operations, Manage Staging and Finished Product Warehouse. Proven track record of leading teams to produce high quality products in a safe and cost effective manner. New production Line start-up of Formulation, Aseptic Filling, and Packaging.
Overview
35
35
years of professional experience
Work History
Manager
BioMerieux
12.2021 - Current
- Manage and schedule daily production activities of 10 direct reports in Media Formulation, Bulk weighing and equipment preparation
- Initiate and implement change controls to reduce operator errors and improve productivity
- Ensure departmental/site KPI's are achieved
- Attend daily schedule meetings to ensure weekly production goals and metrics are achieved
- Performance reviews of direct reports
- Mentor and cross-train team members
- Initiation and implementation of CCR's (Change Control Request)
- Implement work requests using Blue Mountain
- Interview potential candidates.
- Cross-trained existing employees to maximize team agility and performance
- Maximized performance by monitoring daily activities and mentoring team members
- Onboarded new employees with training and new hire documentation
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground
- Managed and motivated employees to be productive and engaged in work
Formulation Supervisor
BioMerieux
08.2020 - 12.2021
- Managed and scheduled daily production activities of 6 direct reports in Media Formulation and equipment preparation
- Performed final review of batch records and supporting documentation
- Reduced cycle time by implementing inventory management procedure
- Revised documentation to reduce repetitive transcription errors
- Suggested/implemented process and documentation improvements
- Maintain production areas in state of inspection readiness
- Maintained detailed performance records of direct reports to be used during semiannual/annual reviews
- Implemented cross training programs for team members
- Time management of direct reports.
Formulation Supervisor for Product Development Services
ThermoFisher Scientific
07.2019 - 08.2020
- Manage and schedule daily production activities of 7 direct reports in Bulk Formulation, Vial Filling, Equipment/Component preparation and sterilization and Aseptic area decontamination
- Time management of direct reports
- Administer disciplinary actions
- Final review of batch records and supporting documentation
- Reduced repetitive steps in process documentation
- Maintain productions areas in state of inspection readiness.
Senior Lead Aseptic
Genzyme Biosurgery Sanofi
02.2007 - 06.2019
- Manage and schedule daily production activity of 9 team members in Bulk Formulation, Vial Filling, Equipment/Product sterilization and packaging operations
- Attend daily Management Improvement and scheduling meetings
- Performed final Management review of Production Batch records and supporting documentation
- Initiate and investigate process deviations using Trackwise
- Implement training and cross training programs for new hires and current team members
- Suggest and Implement cost-saving, safety and production improvement recommendations
- Participated in Operational Excellence Efficiency workshops
- Work closely with outside vendors for equipment purchases and troubleshooting of equipment issues.
Senior Production Specialist
Hoffmann- La Roche Inc
12.2005 - 02.2007
- Fed batch cell culture using 30L, 400L, and 2000L Bioreactors
- Operation and troubleshooting if large scale Bioreactor Systems
- Perform preventative maintenance of Bioreactors during production shutdown
- CIP/SIP of process equipment Bioreactor Systems
- Preparation and filtration of Media use in large scale production
- Monitoring of processes using Mettler Toledo pH and dissolved oxygen transmitters
- Cell counting using Cedex Cell analyzer
- Order and issue components for manufacturing, using SAP computerized inventory system.
Pharmaceutical Production Operator/Production Specialist
Hoffmann-La Roche
03.1989 - 12.2005
- Worked with engineering department on offsite projects and final onsite qualification of Syringe Packaging Line
- Authored SOP's for new packaging cartoner
- Performed IQ/OQ of MGS Syringe packaging equipment
- Attended FAT (Factory Acceptance Test) of new packaging cartoner
- Large scale bulk manufacturing/filtration of biological and terminally sterilized solution
- Production sterilization of Syringes, Vials and Ampoules
- Operation, set-up and troubleshooting of large scale Lyophilizes
- CIP/SIP of stainless steel and glass lined manufacturing vessels used in bulk compounding
- Set-up, operated, maintained, disassembled and cleaned equipment for aseptic vial and syringe filling lines
- Environmental monitoring of aseptic processes using viable and non-viable monitoring equipment.
- Parts preparation and sterilization of Aseptic Filling equipment and container components
- Operated packaging and labeling equipment on solid and liquid dosage production lines
- Managed daily activities of Component Staging and Finished Products Warehouse
Education
Some College (No Degree) -
Passaic Community College
Paterson, NJHigh School Diploma -
Passaic High School
Passaic, NJ06.1988
Skills
- Management of multiple direct reports
- Change Control
- New Production line start up
- Author and revise SOP's and Manufacturing documents
- Time Management
- Microsoft Office Suite
- Communication
- Problem Solving
- Root Cause Analysis
- Inventory Management
- Process Improvement
- Continuous Improvements
- Mentor and Coach Direct Reports
- Implementation, Investigation and Closure of Process Deviations
- Aseptic Filling and Formulation
Training
Critical Thinking, Making Quality Decisions , Aseptic Growing Certified, Fermentation Methods and Scale Up Strategies, Conflict Resolution , Emotional Intelligence Course
Timeline
Manager
BioMerieux
12.2021 - Current
Formulation Supervisor
BioMerieux
08.2020 - 12.2021
Formulation Supervisor for Product Development Services
ThermoFisher Scientific
07.2019 - 08.2020
Senior Lead Aseptic
Genzyme Biosurgery Sanofi
02.2007 - 06.2019
Senior Production Specialist
Hoffmann- La Roche Inc
12.2005 - 02.2007
Pharmaceutical Production Operator/Production Specialist
Hoffmann-La Roche
03.1989 - 12.2005
Some College (No Degree) -
Passaic Community College
High School Diploma -
Passaic High School