Cherell Harris, Esq., Pmp, Lssbb Email & Phone Number

Durham, NC, US

Raleigh, NC, US

Raleigh, NC, US

Durham, North Carolina, US

• Managed portfolio of 12-14 current and prospective product development projects to bring vaccines for Phase I clinical trials, including timelines for specific deliverables and budgets.
• Supervised project managers and cross-functional teams responsible for development, planning, execution, project controls, communication plans and risk management. Synthesized input for compliance and reporting.
• With Director of IP and Contracts Manager, negotiated material transfer agreements, master service agreements, technology licenses, and research science service agreements. Developed and reviewed scope of work.
• Served as area SME during development of budget and technical proposals for response to government RFPs for GMP vaccine manufacturing contract and grant submissions.
• Met with U.S. NIH and DARPA officials, drafted and submitted memoranda regarding project progress. Collaborated with subject matter experts (SMEs) and other internal and external stakeholders to ensure full compliance.

Durham, North Carolina, US

• Supported the Duke Human Vaccine Institute (DHVI) GMP Program’s strategic mission through management of the DHVI GMP product portfolio via the development of strategic portfolio planning tools and procedures with.
• Reviewed resource and staffing requirements for manufacturing campaigns to ensure alignment with budget and GMP facility parameters.
• Led cross functional teams with responsibility for project development, planning, execution, project controls, communication plans and risk management across multiple projects. Collaborated with subject matter experts.
• Routinely coordinated with stakeholders, internal and external, to provide project updates, develop project plans/risk mitigation plans, disseminated results and coordinated acquisition of materials and services..
• Provided project management coaching and mentorship to members of the GMP team, and developed junior project management staff to drive continuous improvement required to maintain a rapidly expanding pipeline of products.

Rahway, New Jersey, US

• Led various teams of Subject Matter Experts (SMEs) in completion of quality risk assessments to ensure implementation of Annex 1 European Union Regulatory Standards in 2019.
• Performed quality review and approval of product impact assessments, Quality Notifications (QNs) and related Corrective and Preventive Actions.
• Served as site SME for sterility assurance related investigations and regulatory body inspections.

Rahway, New Jersey, US

• Led Quality Assurance Batch Release team, including prioritization and resolution of issues related to batch release such as: completion of required release testing, timely Quality Notifications (QN) closure, genealogy.
• Led team execution of Sterility Assurance protocol designed to assess and improve the Sterility Assurance program.
• Certified as Quality Risk Management (QRM) Risk Assessment facilitator.

Rahway, New Jersey, US

• Led team of Sterility Assurance Engineers responsible for administration and maintenance for the site Process Simulation and Sterility Assurance programs.
• Led three separate root cause investigation teams through two Process Simulations and one Product Sterility Positive investigation which helped company avoid $60MM loss. Subsequently led the effort to perform repeat.
• Participated on Global team that authored Standard Business Practice SBP guidance document for Sterility Investigations.
• Worked on project to preemptively determine process risk as part of site business continuity plan, including detailed risk assessments for the Pooling Sonication Filtration processing area.

US

• Worked with clients to assess ability to file patent applications for their inventions.
• Conducted client intake interviews and completed associated intake documentation.
• Searched USPTO registered patent database.
• Authored memorandums informing clients of search results and presented recommendations for likelihood of proceeding to registration based on the Patent Manual of Examining Procedure.
• Drafted Provisional Patent Application for client.

US

• Worked with clients to assess ability to file trademark applications for their marks.
• Searched USPTO registered trademark database using Corsearch.
• Authored memorandums and presented recommendations to client on likelihood of proceeding to registration based on the Trademark Manual of Examining Procedure.
• Filed Intent to Use Application for client.

Bridgewater, NJ, US

• Mentored Green Belt in a Six Sigma Black Belt certification process project to reduce waste & improve yield for a new product launch. Coached green belt project team which resulted in reduction in equipment downtime in.
• Led PFMEA activities for various new product launches, process improvements and project teams.
• Created Value Stream Maps (VSM), detailed process flows, Voice of Customer (VOC) analysis and PFMEA creation for Manufacturing Operations to support the implementation of CAMS electronic batch record system and support.
• Provided monthly SPC trend analysis for highest volume lens care solution products. Leads teams on projects to reduce overall process variation and implement statistical process control.
• Supported plant operations as (SME) performing detailed root cause investigations for complex nonconformance issues using Is/Is Not, 5-Whys, Fishbone, Is/Is Not, Screen Tool, Contradiction Matrix root cause.
• Led and mentored project teams to address business process bottlenecks and design of process enhancements using Six Sigma DMAIC, Lean and DFSS (Design for Six Sigma) tools.

Bridgewater, NJ, US

• Led and participated in nonconformance and customer complaint investigations and CAPA implementation activities that directly impacting several production areas using 5-Why, Fishbone (Ishikawa) and additional root.
• Provided support and direction to production personnel related to the evaluation of quality related to daily issues that occurred during product manufacturing.
• Implemented the use of statistical analysis for determination of areas for potential improvements, and provided analyses to support risk mitigation.
• Performed data analysis for quality metrics inputs into the Management Review and Annual Product Review (APR) processes.
• Led PFMEA activities for various new product launches, process improvements and project teams. Served as Quality area SME for new product and process transfers to ensure proper development of design/process.

Bridgewater, NJ, US

• Authored, reviewed and implemented procedures to drive supplier’s quality processes for continuous improvement.
• Led site Supplier Management Team (SMT) to ensure resolution of supplier quality problems by managing supplier investigation of root cause and corrective action planning and implementation.
• Partnered with suppliers / vendors upstream of the plant core processes to facilitate continuous improvements that reduced the overall Costs of Quality (COQ). Conducted Supplier site audits and quality improvement.
• Led the site advanced quality planning and qualification activities for approving new and changes to existing components and suppliers, including the authoring, execution and approval of validation protocols.
• Performed tracked and trended key supplier quality performance metrics as input into APR process. Presented Supplier Quality metric during annual Management Review meeting.

Lake Forest, IL, US

• Completed black belt certification project reducing excess solution loss in the Small Volume Parenterals (SVP) solution preparation department. Completed six additional black belt projects utilizing the DMAIC.
• Completed projects which removed non-value added sample testing and changeover time that resulted in over $300K in direct cost.
• Mentored two green belt teams through completion of certification projects in the Biological Quality Lab and SVP Filling areas resulting in over $52K in cost reduction savings.
• Co-led lean manufacturing training event in the Supplier Quality area that decreased incoming quality sampling turnaround time resulting in a $72K cost reduction.
• Led project to perform validation of upgraded version of Minitab software.

Lake Forest, IL, US

• Directed daily shift activities for a team of Manufacturing Quality Inspectors and Manufacturing Quality Auditors, ensuring job duties were performed efficiently and effectively to meet department daily and yearly.
• Ensured manufacturing personnel adhered to required Standard Operating Procedures (SOPs) during daily operations.
• Reviewed and approved completed batch record documentation in order to maintain outstanding customer service at 98.8%. Performed product release, quality holds and disposition evaluations for potential nonconforming.
• Composed and tracked exception documentation for the Flex Quality organization using the QAETS and CAPA systems.
• Served as area Quality SME for internal and external audits.
• Performed root cause investigation and provided responses to customer product complaints.

Corning, New York, US

• Directed daily shift activities for nine production associates and one degreed shift technician in a High Performance Work System. Coached production employees, ensuring job duties were performed efficiently and.
• Conducted system audits to ensure efficient utilization in two optical fiber manufacturing areas. Co-led daily production meetings to report on metrics and determine daily production priorities.
• Assisted plant engineering with special projects designed to maximize equipment utilization and decrease product defect issues
• Developed computer program to track monthly maintenance and parts expenditures. Program helped to identify and reallocate incorrect charges to other departments, resulting in a 35% decrease in maintenance parts expenses.

Minneapolis, Minnesota, US

• Provided technical expertise to resolve daily production issues on the Chex cereal systems. Trained shift production team leaders on technical aspects of system operations. Developed and conducted training for.
• Worked closely with R&D engineers by performing experiments for process improvement and implementing new product recommendations for the plant.
• Co-led efforts to reduce ingredient overuse on the slurry coated cereal system for the Chex Franchise. Involved in the design, implementation and operator training for a $250K process improvement that resulted in a.

Minneapolis, Minnesota, US

• Designed and conducted a study that evaluated the potential use of volumetric fillers in the packaging area.
• Spearheaded a focused improvement team to optimize the CIP system in the Ready-To-Spread Frosting area. Team effort resulted in a 40% reduction in required cleaning time.
• Worked with several cross-functional teams to evaluate, improve and optimize daily manufacturing operations for a product in the Fruit Department. Coordinated efforts of efficiency team, which included improving system.
• Provided sanitation, regulatory and consumer requirements training to operators, technicians, mechanics and engineers to ensure regulatory compliance.

Doctor Of Law (J.D.), Intellectual Property Law

Master Of Engineering (Meng), Chemical Engineering (Mse)

Education record

Bs, Chemistry

Education record