Keith Nelson
Inwood,WV
Summary
Dynamic and professional with over 28 years of experience in pharmaceutical manufacturing and management across research and cGMP environments. A creative manager with strong quantitative, problem-solving, and leadership skills, focused on enhancing team capabilities, managing risks, and improving cGMP procedures and business practices in clinical manufacturing. Proven ability to advance organizational goals through managing and training a workforce of 10 and coordinating with up to 8 other departments. Concurrently performed work on multiple client processes with perfect delivery in aseptic operations over the last 5 years, receiving strong positive feedback from clients for client engagement and product delivery. Seasoned and empathetic leader who leads by example, leveraging years of military service and 20 years of coaching volleyball to create and build dedicated, responsive, and flexible teams. Strives to understand the perspective of all stakeholders - the team, the business, and the clients - to drive win-win outcomes.
Overview
23
23
years of professional experience
Work History
manufacturing manager
IDT Biologika Corp.
08.2023 - 09.2024
- Designed manufacturing processes using scientific and mathematical principles.
- Operated and maintained mechanical equipment, including fermenters, bioreactors, ÄKTApilot, ÄKTAprocess, TFF systems, and buffer preparation systems
- Spearheaded USP/DSP initiatives by overseeing equipment, batch records, SOPs, and materials.
- Resolved Deviations, CAPAs, ICARs, and drove continuous improvement initiatives
- Conducted in-process assays to monitor performance
- Assisted in scaling up and executing non-GMP USP & DSP procedures, supporting the MSAT organization
- Ensured adherence to health and safety guidelines for handling hazardous materials
- Developed metrics databases to identify trends in manufacturing operations
- Drove performance and recruitment of direct and indirect reports within Manufacturing
- Implemented performance management to develop and mentor employees, ensuring proper training
- Established relationships with internal and external clients to ensure best practices for vaccine manufacturing
- Participated in technology transfer of USP, DSP, and bulk fill procedures
- Supported external meetings and built relationships with external manufacturing entities
- Maintained process status reports and KPIs to track program progress
- Provided expert guidance on contract-related matters.
Manufacturing Sr. Supervisor
IDT Biologika Corp.
05.2022 - 08.2023
- Managed daily operations of the Vaccine Manufacturing Area facility, overseeing Upstream, Downstream, and Fill-Finish areas
- Acted as subject matter expert in the development of manufacturing documents, including site-wide documents
- Screened, hired, trained, coached, and counseled technicians, leads, and supervisors
- Interfaced with clients during technology transfer and manufacturing processes
- Acted as Manufacturing Subject Matter Expert for the development and deployment of operational excellence projects
- Implemented a qualification-based training program for technicians
- Introduced a Kanban system
- Established a Gemba Walk program
- Implemented Kaizen management principles
- Oversaw site 5S, Kanban, and Right First Time teams
- Conducted technology transfer, risk/impact analysis, process redesign for scaling up from process development to GMP phase, equipment qualification and repair, lot tracking file design and maintenance, and implementation of unit operations
- Reestablished the company's aseptic fill-finish team after turnover
- Worked with aseptic filling technologies, including variable filling head height, nitrogen overlay, adaptation to multiple vial sizes/types, and Lyophilization technologies for up to 10,000 vial fills
- Managed projects involving new documentation generation, training, technical assessment, fill line upgrades, and vendor coordination across multiple departments
Manufacturing Supervisor
IDT Biologika Corp.
09.2020 - 05.2022
- Designed, developed, and deployed various manufacturing processes
- Conducted technology transfer and scale-up of Upstream, Downstream, and Fill/Finish procedures
- Revised and updated standard operating procedures, batch records, and other manufacturing documentation
- Developed and maintained metrics databases to identify trends and drive continuous improvements
- Assisted Project Management in developing manufacturing Gantt charts
- Investigated and resolved manufacturing-related Deviations and CAPAs
- Assisted in scaling up and executing non-GMP USP & DSP manufacturing procedures
- Supervised production staff in all aspects of USP/DSP operations, including execution, equipment setup and maintenance, and controlled document generation (batch records, SOPs)
- Trained staff on various processes and equipment through pre-briefing, after-action reviews, and on-the-job training
- Assisted in the development and execution of process equipment validation protocols
- Followed health and safety guidelines when handling chemical, radiological, and BSL-1 and BSL-2 hazardous materials
- Implemented and maintained various operational excellence initiatives, including Kanban, 5S, Right-First-Time, and Lean Six Sigma
- Applied performance management to develop, evaluate, and mentor employees, ensuring proper training and development
- Troubleshot, maintained, and cleaned bioprocess equipment and facilities
Manufacturing Associate III, Team Lead
IDT Biologika Corp.
11.2018 - 09.2020
- Designed, developed, and deployed various manufacturing processes
- Conducted technology transfer and scale-up of Upstream, Downstream, and Fill/Finish procedures
- Revised and updated standard operating procedures, batch records, and other manufacturing documentation
- Developed and maintained metrics databases to identify trends and drive continuous improvements
- Assisted Project Management in developing manufacturing Gantt charts
- Investigated and resolved manufacturing-related Deviations and CAPAs
- Assisted in scaling up and executing non-GMP USP & DSP manufacturing procedures
- Supervised production staff in all aspects of USP/DSP operations, including execution, equipment setup and maintenance, and controlled document generation (batch records, SOPs)
- Trained staff on various processes and equipment through pre-briefing, after-action reviews, and on-the-job training
- Assisted in the development and execution of process equipment validation protocols
- Followed health and safety guidelines when handling chemical, radiological, and BSL-1 and BSL-2 hazardous materials
- Implemented and maintained various operational excellence initiatives, including Kanban, 5S, Right-First-Time, and Lean Six Sigma
- Applied performance management to develop, evaluate, and mentor employees, ensuring proper training and development
- Troubleshot, maintained, and cleaned bioprocess equipment and facilities
Research Associate IV
Sanaria, Inc.
01.2005 - 01.2018
- Participated in the vaccine extraction process for the production of a whole-parasite malaria vaccine in BSL-II and cGMP/GLP environments
- Prepared mosquito growth medium in compliance with Good Manufacturing Practices (GMP)
- Produced and reared mosquitoes at various stages of growth for vaccine production
- Conducted infectivity assessments to determine infection rates of produced mosquitoes
- One of three employees entrusted with the mosquito irradiation process for vaccine production
- Managed all aspects of laboratory and equipment maintenance and troubleshooting for the Mosquito Production team
- Maintained a mosquito insectary with over 300 trays
- Assisted in developing a new dissection configuration for Phase II product, significantly reducing contamination and increasing dissection yield by 20%
- Developed and optimized a new mosquito rearing container, decreasing mosquito die-off and tripling production capacity and infectivity
- Maintained process records to assess production efficiency and determine the need for capacity increases
- Led training for incoming employees and third-party contractors on updated processes
- Organized educational seminars for third-party visitors to highlight the importance of STEM education and research and development
Automation Specialist I/Section Leader
J. Craig Venter Science Foundation Joint Technology Center
01.2002 - 01.2005
- Ensured that manufacturing operations were performed on schedule
- Reconciled all procedural changes and reported deviations/problems
- Implemented process improvements developed by R&D
- Revised SOPs to ensure greater clarity and ease of use, ensuring consistent process performance by all employees
- Coordinated scheduling, workload, and improvement initiatives with management staff and R&D personnel
Education
General Biology -
Hagerstown Community College
Hagerstown, MDAssociate Degree - Criminal Justice
Jefferson Community College
Watertown, NYCertificate - Primary Leadership Development Course
U.S. Army
04.1994
Certificate - Nuclear Biological Chemical Defense Course
U.S. Army
08.1993
Diploma - Military Police Course
U.S. Army
11.1989
Skills
- Manufacturing technologies
- Customer support
- Strategic thinker
- Production procedures
- Health and safety compliance
- Operations management
- Team supervision
- Material handling expert
- Continuous improvement
- New employee hiring
- Priority management
- Production planning
- Internal auditing
- Waste reduction
- Production scheduling
- ISO standards
- Process improvement
- Data analytics
- Forecasting
- Lean manufacturing techniques
- Lean manufacturing
- Cost reduction strategies
- Process scheduling
- Quality assurance authority
- Safety and quality standards
- Scheduling and forecasting
- Microsoft applications skills
- Teamwork and collaboration
- Problem-solving
- Time management
- Attention to detail
- Problem-solving abilities
- Multitasking
- Reliability
- Critical thinking
- Verbal and written communication
Publications
- Mark D. Adams, et. al., The Genome Sequence of Drosophila Melanogaster, Science. 287:2185-95.
- J. Craig Venter, et. al., The Sequence of the Human Genome, Science. 291:1304-1351.
- Robert A. Seder, et. al., Protection Against Malaria by Intravenous Immunization with a Nonreplicating Sporozoite Vaccine, Science. VOL 341 20 September 2013.
Software Skills
ComplianceWire, NextDocs, TrackWise, SAP, Kronos, Workday, Paycor, eTimesheets, Boxstorm, Visio, Project, Word, Excel, Powerpoint, Publisher
Timeline
manufacturing manager
IDT Biologika Corp.
08.2023 - 09.2024
Manufacturing Sr. Supervisor
IDT Biologika Corp.
05.2022 - 08.2023
Manufacturing Supervisor
IDT Biologika Corp.
09.2020 - 05.2022
Manufacturing Associate III, Team Lead
IDT Biologika Corp.
11.2018 - 09.2020
Research Associate IV
Sanaria, Inc.
01.2005 - 01.2018
Automation Specialist I/Section Leader
J. Craig Venter Science Foundation Joint Technology Center
01.2002 - 01.2005
General Biology -
Hagerstown Community College
Associate Degree - Criminal Justice
Jefferson Community College
Certificate - Primary Leadership Development Course
U.S. Army
Certificate - Nuclear Biological Chemical Defense Course
U.S. Army
Diploma - Military Police Course
U.S. Army
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