Kayla Herb, Mba Email & Phone Number

Southern Pines, Nc, Us

Developed and implemented a proactive monitoring system (patent pending #63/663,966) as the Analytics lead of the Intelligent Monitoring team to manage risk associated with prior authorization processes and to provide actionable insights for further process refinement improving provider-payer relations and patient experiences. § Designed and enacted a risk detection methodology to identify unacceptable technology portfolio risk, investigated unforeseen impacts of automation, and developed solutions to address identified root causes and proactively improved the mechanism for further impact identification.§ Lead strategic analysis, planning, operational execution of healthcare transformations to optimize healthcare utilization, reduce total cost of care, and improve health outcomes through innovation and advanced risk mitigation. § Conducted detailed operational analysis on innovative techniques, e.g., cognitive & generative Artificial Intelligence (AI) to increase efficiency and innovation working with variety of enterprise stakeholders.

San Diego, California, United States

• Workstream lead for a highly cross-functional team of approximately fifty engineers and scientists with a mission to transfer new reagent manufacturing processes from development in the United Kingdom to manufacturing in San Diego, CA which support the successful launch of NovaSeq X and NovaSeq 6000DX platforms• Technical consultant for the development and stand-up of a new manufacturing site in the United Kingdom• Directly managed team of five engineers and chemists to support optimization and change management of on-market manufacturing processes and transfer of new manufacturing processes• Project lead for review of existing reagent subcomponent transfer and maturation processes and subsequent process optimization, standardization, and implementation to promote best practices within the company• Member of an asset strategy team advising on long-term initiatives to improve and grow company value streams• Presented strategic vision for future of process transfer based on historical analysis, expense and time-to-market optimization, and standardization to senior leadership team with successful reception and implementation approval

San Diego, California

• Technical lead for a highly cross-functional team of approximately twenty engineers and scientists with a mission to transfer new reagent manufacturing processes from development in the United Kingdom to manufacturing in San Diego, CA which support the successful launch of the NextSeq 1000/2000 sequencing platforms• Managed strategic analytical method development portfolio supporting critical reagent product line to drive transition from functional to analytical product quality control enabling cost reduction• Oversaw the successful onboarding process and directly managed a remote employee during COVID-19 to deliver a cost savings proposal (>$150k annually) with technical and business analysis • Led operational analysis and selection of manufacturing sites based on core competencies, labor and facilities cost, product sensitivities, and logistical criteria• Created material forecasts and manufacturing capacity models for new product introductions to identify and implement proper scale processes and prevent supply disruptions for critical sequencing reagents• Advised on technical components of projects with contract suppliers and served as technical lead for supplier audits• Trained engineering team members on process catch activities, sustaining activities, and project management principles

San Diego, California

• Technical area lead for catch of reagent manufacturing processes from development in the UK to manufacturing in San Diego to support NovaSeq 6000 and iSeq sequencing platform launches• Transferred manufacturing processes for diagnostic reagents to new equipment by demonstrating equivalency between equipment design and functionality• Developed documentation structure for complex process control structure highlighting controls, analytical technologies used, and criticalities of each step• Designed laboratory requirements and served as technical lead for the construction and development of two new manufacturing laboratory spaces• Trained engineering team members on sustaining activities i.e. production support, NCR writing/approvals

Greater San Diego Area

• Created a process for performing construction in a manufacturing environment with controls for contamination working with cross-functional teams• Served as a subject matter expert for FDA PMA audits, BSI/ISO, and customer audits• Evaluated non-conformance events and performed daily sustaining activities such as deviations supporting reagent manufacturing• Designed and implemented 21 CFR Part 11 software controls to existing manufacturing• Mitigated end of life equipment by demonstrating equivalency and implementing new equipment in reagent manufacturing

Greater San Diego Area

-Designed, characterized, and validated processes for oligonucleotide manufacturing-Wrote manufacturing protocols and supporting documentation

Baltimore, Maryland Area

- Coordinate and run biweekly meetings for the HHS Leadership Board- Work as a member of the executive staff in order to plan and coordinate the overnight events offered to prospective students- Coordinate all student staffing required for the overnight events- Schedule and reserve spaces for events and overnights-Coordinate all details pertaining to a cultural performing arts showcase

San Jose, Ca

- Worked as part of the research and development team to test and implement a new platform for the Harmony prenatal diagnostic test- Worked independently to develop a protocols and procedures to improve upon current standard operating procedures

Johns Hopkins University

- Assisted various graduate students with research projects within the field of tissue engineering- Independently maintained and supported lab functions through lab chores through autoclaving equipment and stocking biological hoods and dissection stations

San Luis Obispo, California Area

- Performed maintenance on tissue embedding machine and other lab equipment- Sectioned and stained tissues to determine the best possible histology protocols and to improve analysis of collaterals

San Luis Obispo, California Area

- Performed histology under the direction of Dr. Kristen Cardinal to analyze tissue-engineered blood vessels- Developed a protocol for staining tissue engineered constructs increasing the retention rate by approximately 300%- Worked independently in the lab and as part of a research team during lab meetings

Master Of Business Administration - Mba

Activities and Societies: Beta Gamma Sigma HonorsConcentrations: Public & Private Sector Leadership | HealthCare Management, Innovation &.

Bachelor Of Science (B.S.), Biomedical Engineering

Activities and Societies: BMES, SHPE, HHS Executive Board, Academic Ethics and Conduct Board Presiding Official, JHU CheerleadingMinors.

High School Diploma