Keith Nelson

• Supervised manufacturing operations and personnel, ensuring compliance with cGMP, regulatory requirements, and organizational standards.
• Directed batch record reviews and partnered with QA to achieve 100% documentation compliance and timely batch close-outs.
• Trained and coached staff on cGMP, documentation, and safety protocols, boosting efficiency and accuracy.
• Led investigations, deviations, and CAPA closures, driving continuous improvement and compliance.
• Built and managed high-performing teams, overseeing recruitment, onboarding, performance management, and career development.
• Collaborated with cross-functional teams to execute production campaigns on time and within quality standards.
• Authored and revised SOPs, implemented process efficiencies, and improved documentation review turnaround times.
• Represented manufacturing in client projects and cross-functional initiatives, providing technical expertise and ensuring project success.

• Directed upstream and downstream manufacturing operations (USP, DSP, bulk fill), ensuring equipment readiness, regulatory compliance, and successful technology transfers.
• Built and led high-performing teams through recruitment, training, and performance management, mentoring staff to enhance technical expertise and GMP compliance.
• Oversaw resolution of deviations, CAPAs, and ICARs, driving corrective/preventive actions and embedding a culture of continuous improvement.
• Developed and managed manufacturing KPIs and status reports to monitor progress, optimize efficiency, and support executive decision-making.
• Partnered with internal stakeholders and external CMOs to align on best practices, ensuring seamless collaboration and delivery of vaccine manufacturing programs.
• Provided strategic guidance on operations and contracts to ensure organizational goals were achieved.

• Directed daily operations of vaccine manufacturing across Upstream, Downstream, and Fill-Finish areas.
• Served as Subject Matter Expert (SME) for manufacturing documentation, technology transfer, and operational excellence initiatives.
• Rebuilt and led the aseptic fill-finish team post-turnover; implemented advanced aseptic technologies (variable head height, nitrogen overlay, lyophilization) for batches up to 10,000 vials.
• Oversaw technology transfer and scale-up from process development to GMP, including risk/impact analysis, process redesign, equipment qualification, and lot tracking system design.
• Implemented Lean programs (Kanban, Gemba Walks, Kaizen, site-wide 5S), improving efficiency, reducing waste, and driving a “Right First Time” culture.
• Designed and launched a qualification-based training program for technicians; recruited, trained, and coached staff from technician to supervisor levels.
• Partnered with clients during manufacturing and technology transfer to ensure compliance, successful execution, and strong relationships.
• Led cross-functional projects in documentation creation, training deployment, technical assessments, fill line upgrades, and vendor coordination.

• Supervised production staff in upstream and downstream operations, overseeing execution, equipment setup, and GMP documentation to ensure compliance and operational excellence.
  
  • Trained, mentored, and evaluated employees, driving skill development, readiness, and adherence to quality standards.
  
  • Directed technology transfer, scale-up, and validation activities for manufacturing processes and equipment, ensuring smooth transitions and regulatory compliance.
  
  • Led deviation investigations and CAPA resolutions, identifying root causes, implementing corrective actions, and preventing recurrence.
  
  • Reviewed, revised, and approved SOPs, batch records, and GMP documentation, strengthening compliance and supporting continuous operations.
  
  • Applied Lean Six Sigma, Kanban, and 5S methodologies to streamline workflows, reduce waste, and improve production efficiency.
  
  • Tracked and analyzed production metrics, identifying trends, improving performance, and supporting project planning and execution.

• Designed, scaled up, and transferred upstream, downstream, and fill/finish processes, supporting both GMP and non-GMP activities.
• Authored and revised controlled documentation, including SOPs, batch records, and validation protocols.
• Supervised and trained production staff in USP/DSP operations, equipment setup/maintenance, and compliance practices.
• Investigated deviations/CAPAs and implemented process improvements using Lean Six Sigma, 5S, and Right-First-Time principles.
• Developed metrics dashboards and Gantt charts to track manufacturing performance and project timelines.
• Ensured compliance with health, safety, and regulatory standards while handling hazardous materials.

• Technical & Laboratory Expertise
• Participated in vaccine extraction for whole-parasite malaria vaccine production within BSL-II and cGMP/GLP environments.
• Prepared mosquito growth medium in compliance with Good Manufacturing Practices (GMP).
• Produced and reared mosquitoes across multiple life stages to support vaccine development.
• Conducted infectivity assessments to evaluate infection rates in laboratory-produced mosquitoes.
• Entrusted as one of three employees responsible for mosquito irradiation for vaccine production.
• Maintained and managed a mosquito insectary with 300+ trays.
• Oversaw laboratory and equipment maintenance, troubleshooting, and process optimization for the Mosquito Production team.

Process Optimization & Innovation

• Co-developed a new dissection configuration for Phase II vaccine production, reducing contamination and increasing yield by 20%.
• Designed and optimized a new mosquito rearing container, reducing mortality and tripling production capacity and infectivity.
• Tracked and analyzed process records to evaluate efficiency, improve workflows, and forecast capacity needs.

Leadership & Training

• Trained new employees and third-party contractors on laboratory protocols and updated production processes.
• Organized and led STEM-focused seminars for external visitors, highlighting the importance of scientific research and development.

• 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