Dianne Mitchell, Phd Email & Phone Number

United States

United States

•Provided biomedical consulting services for next generation sequencing (NGS) and cell therapy collection companies, focusing on the implementation of in-house sequencing, production of cell therapy products, and the establishment of a robust quality and process control framework. This included developing an ISO 9000/ ISO 15189 audit program to ensure ongoing compliance with industry standards.•Managed client-partner initiatives and issues, collaborating with relevant departments to streamline workflows, develop SOPs, and implement effective solutions. Led the management review process to evaluate project progress, ensuring that all quality criteria were met and process improvements were identified and enacted.•Conducted program reviews to maintain alignment and drive program success through comprehensive assessments of quality and laboratory programs, utilizing quality tools to ensure compliance with regulatory requirements and operational standards.•Identified and secured support and resources to strengthen partnerships and overcome obstacles to growth and development, including conducting routine risk assessment activities to proactively identify potential challenges and mitigate risks.•Implemented measures to analyze key quality metrics and operational performance, facilitating data-driven decision-making to enhance service delivery and operational efficiency, while also providing a quality interface between clients and relevant stakeholders.•Developed and executed strategies to manage revisions of process control documents and standard operating procedures (SOPs) to ensure they were up-to-date and effective in guiding laboratory operations, contributing to the overall success of client projects.•Drove problem-solving initiatives that addressed complex client needs and challenges, ensuring that the implementation of quality standards and controls was successful, thereby fostering sustainable growth in client operations.

El Paso, Texas Area

•Co-founded and led a clinical cancer diagnostics and contract research company focused on next-generation sequencing (NGS), driving the establishment of a comprehensive Quality Management System (QMS) aligned with ISO 9000 standards and ISO 15189 to support rigorous testing and inspection processes.•Directed the development and ongoing management of clinical Standard Operating Procedures (SOPs) and led assay validation studies to ensure that all quality criteria were met consistently across operations, utilizing quality tools to ensure compliance and adherence to high QA/QC standards.•Designed and implemented an internal ISO 9000 and ISO 15189 audit program and managed the corrective action and management review processes to identify, document, and address non-conformities, and maintain continuous quality improvement.•Analyzed key quality metrics and manufacturing process metrics to ensure operational efficiency, identifying and driving process improvements and resolutions to complex manufacturing and testing issues.•Conducted routine risk assessment activities, including problem-solving initiatives, to proactively address potential risks in equipment, instrumentation, and assay performance, ensuring operational reliability and quality readiness.•Maintained a quality interface with accrediting bodies such as CLIA and COLA as well as other regulatory agencies, ensuring all laboratory standards met compliance requirements and were consistently monitored across federal, state, and local levels. Directly engaged with auditors and regulatory bodies to demonstrate compliance during on-site visits.•Collaborated with team members to manage revisions of process control documents, such as control plans and PFMEAs, to ensure alignment with regulatory requirements, and enhance quality standards.

Las Cruces, New Mexico Area

•Supervised high-level lab operations and assay development for the clinical pharmacogenomics (PGX) testing laboratory, setting goals, monitoring work, and evaluating results to ensure all quality criteria and operational objectives were met.•Directed comprehensive administrative management for the clinical lab, including human resources (performance management), financial management, and IT, with a focus on implementing and managing the Laboratory Information Management System (LIMS) to ensure compliance and improve process efficiency.•Led efforts in problem-solving and process improvements across lab functions, implementing quality tools to ensure compliance and preparing for future growth through strategic planning and alignment with long-term company objectives.•Conducted management review processes with the Executive team, serving as a quality interface between departments to assess key quality metrics and discuss manufacturing process metrics for continuous improvement and growth.

Las Cruces, New Mexico

•Managed all clinical pharmacogenomics (PGX) laboratory operations and staff, ensuring high levels of customer satisfaction by implementing process improvements and resolving issues effectively.•Directed a Laboratory Quality Management Program, ensuring compliance with federal and state regulations through continuous monitoring, proficiency testing, and risk assessment activities.•Developed and managed revisions of Standard Operating Procedures (SOPs), maintaining process control documents to ensure alignment with regulatory standards and high analytical quality.•Conducted routine risk assessment activities and implemented quality tools to ensure compliance, monitoring key quality metrics to identify opportunities for process improvements and maintain operational excellence.•Managed capital equipment agreements, negotiated contracts, and oversaw purchases, optimizing laboratory resources while ensuring readiness for regulatory audits.

El Paso, Texas

•Directed the daily operations of an academic genomics core research facility, ensuring compliance with regulatory standards and optimizing core services (NGS, gene expression, microRNA profiling) through regular problem-solving and process improvements.•Identified emerging genomics technologies, provided a quality interface between lab operations and executive leadership, and guided decisions on equipment needs to support advanced research.•Provided consultative services, support, and training in advanced genomics research, ensuring compliance and alignment with the facility’s quality management goals and standards.•Maintained performance metrics and compliance with quality tools, routinely analyzing key quality and manufacturing process metrics to support continuous improvement and operational efficiency.•Achieved financial performance goals for the research facility, supporting operational sustainability through projections and resource management aligned with organizational priorities.

Cambridge, Massachusetts

-Utilized high-throughput drug library screening assays to develop small molecule therapeutics aimed at preventing protein-protein interactions involved in cancer progression and altering tumor metabolism.PROFICIENCIES: High throughput drug library screening of cultured cancer cell lines.

Greater Boston Area

-Performed pre-clinical drug development of novel anti-cancer and cardiovascular biology therapeutics. -Identified and validated drug targets that served as the basis for new drug development activities, evaluated mechanism of action of pre-clinical drug candidates. -Aided in the identification of biomarkers with which to measure the effect of our drugs in clinical trials. -Authored multiple research papers which relied heavily on extensive collaborations with other departments within the company and in conjunction with outsourced contract research organizations.-Managed one permanent and three temporary direct reports.-Attended and presented at local, national, and international scientific conferences.PROFICIENCIES: Molecular biology techniques, DNA and RNA isolation, PCR, RTPCR, ELISA, microarrays, site directed mutagenesis, small scale protein production and purification, Western, Southern, and Northern blot analysis. Maintenance of diverse mammalian cell lines, production of stable and transiently transfected cell lines. Cell-based assays (phenotyping, cytotoxicity, hemoglobin accumulation, etc.), erythroid differentiation of bone marrow derived stem cells, in vitro analysis (cytotoxicity, phenotyping, reporter gene assay, etc.) to test vasculogenic effects of anti-angiogenic drugs. Flow cytometric immunophenotyping of hematopoietic precursor cells from mouse and human tissues. Utilized western blot gel electrophoresis and flow cytometry to identify drug potency, cell cycle analysis, and downstream signaling effects. Performed in vivo red blood cell biotin conjugation and in vitro protein conjugation. Analyzed microarray and Quantitative PCR data to support mechanism of action studies.

Greater Boston Area

-Utilized cell based assays to determine endothelial cell migration, invasion and capillary formation (including three-dimensional assays and pericyte co-culture assays) in the development of the eye and skeletal muscle.-Isolated cytolysin (a toxin produced by Enterococcus faecalis that lyses human red blood cells) using multiple biochemical techniques (HPLC and mass spectrometry), and examined its mechanism of lytic action.PROFICIENCIES: Bacterial culture, biochemical purification, functional assays with red blood cells. Mammalian cell based assays and animal models of endothelial biology, including co-culture assays of endothelial cells and accessory cells.

Bryan/College Station, Texas Area

-Evaluated the transcriptional regulation of the cancer metastasis suppressor gene KiSS-1 using extensive reporter gene assays. -Performed detailed study of small GTPase expression throughout mouse ocular development using immunohistochemistry. -Examined the role of estrogen receptor alpha secondary mRNA structures toward mediating enhanced stability in endometrial tissues.PROFICIENCIES: RNA purification/stability assays, molecular biology techniques, Northern, Southern. Western blotting. Mammalian and bacterial cell culture. Tissue fixation and processing, immunohistochemistry, pathology. Mouse knockout models, animal husbandry, tissue isolation. Sanger sequencing, luciferase assays, plasmid engineering.

Post-Doctoral Fellowship, Cardiovascular Biology

Doctor Of Philosophy (Phd), Molecular Genetics

Bachelor Of Science, Pre-Veterinary Science

Bioinformatics