Tammy Tomandl

Experience

• 

  Indiana University-Purdue University

  Oct 1990 - Mar 1992

  Senior Research Technician

  Responsible for the organization and management of large laboratory, including all purchasing and inventory. Assisted researchers in various projects involving proteins and kinases.

• 

  Eli Lilly and Company

  Mar 1992 - Aug 1998

  Biochemist

  Developed drug screen and secondary enzyme assays. Optimized automation, reagent purification, kinetic enzyme analysis, and non-linear statistical data analysis.

• 

  Westfield Washington Public Library

  Mar 2000 - Jan 2013

  Homeschool Liaison/Children’s Librarian

  Proposed, developed, and pioneered a model of library programs that 15 years later is still utilized today across Indiana. Acted as a change agent for how Indiana public libraries serve the homeschooling population.

• 

  Quantigen Genomic Services

  Feb 2013 - Feb 2016

  Designed and developed the Quality Management System for data analysis of clinical testing initiatives. Spearheaded inspection preparedness, internal auditing, and technical documents for laboratory accreditation. Organized QA metrics, data collection, and data analysis of clinical laboratory testing and quality control results. Improved employee development through a competency assessment program. Obtained CLIA licensure for the state of California and prepared IQCP documentation for CAP. Completed computer system validation studies for new laboratory information management system (LIMS). Show less Developed pharmacogenomic laboratory testing workflow, specimen processing, reporting results, and client services for physicians. Provided training and medical writing for SOPs, project proposals, Statements of Work, analytical methods, and validation plans. Leveraged expert project management to achieve objectives for pre-clinical research, clinical operations, biomarker assay development, and validation studies. Designed quality management system and quality metrics for GCP, GLP, and ICH guidelines. Managed all aspects of customer service and problem resolution. Implemented the LIMS, collaborated on software development, and tested qPCR workflow. Optimized qPCR assays and developed digital PCR normalization processes. Led vendor management, equipment maintenance, safety compliance, and PGx testing. Supervised and trained laboratory personnel and administrative assistant. Show less

  • Director of Quality and Compliance

    Jul 2015 - Feb 2016

  • Laboratory Manager

    Jun 2013 - Feb 2016

  • Internal Quality Assurance Manager

    Feb 2013 - May 2013
• 

  Hoosier Cancer Research Network

  Feb 2016 - Aug 2021

  Advanced and expanded the translational research capacity at a CRO that supports investigator-initiated Phase I and Phase II multi-site oncology clinical trials. Engaged in scientific exchange and discussion of biomarkers studies with pharmaceutical study funders, academic laboratories, and commercial laboratories. Served as a resource for oncology biomarker research, scientific collaboration, laboratory assays, budgeting, and business partner relationship management. Developed systems and processes to validate account receivables and data reporting for financial accounting of laboratory services. Provided study management for clinical operations. Design and execute biomarker strategies for oncology research in multiple therapeutic areas. Created and launched the Correlative Sciences Clinical Trial Working Group for the Big Ten Cancer Research Consortium and an additional HCRN nationwide network to collaborate on translational strategy and coordinated biomarker research across institutions. Optimized project management for research protocols, budgets, informed consent, and IDEs. Show less Assisted oncology researchers with exploratory studies in pharmaceutical clinical trials. Supplied project coordination, training, and scientific leadership to clinical sites on proper specimen collection and sample processing. Prepared the research design, research methodologies, and SOPs for clinical trials, including laboratory procedure manuals, training materials, and budgets. Enhanced biomarker research development using team management and communication. Developed the process of vendor assessment and qualification for commercial laboratories. Established processes for early study development and created templates for laboratory manuals, training slides, and budgets. Show less

  • Translational Research Consultant

    May 2017 - Aug 2021

  • Clinical Correlative Research Manager

    Feb 2016 - May 2017
• 

  Independent Contractor

  Mar 2019 - Aug 2021

  Scientific Consultant

  Offering quality management and scientific expertise to clients in the biotechnology industry. Head Scientist for startup company offering laboratory testing directly to consumer. Performed analysis of clinical validation documents for point of care SARS-Cov-2 diagnostic lateral flow assay. Drafted scientific documents for regulatory submission to the FDA. Provided management consulting for laboratory startups on FDA regulatory requirements, quality and business development.

• 

  LabConnect

  Aug 2021 - now

  Scientific Project Manager

  From 9/2023 to present: Contracted to a not-for-profit research organization as a BioAssay Operations Manager. Supporting vaccine and treatment clinical trials in low and middle-income countries.From 8/2021 to 9/2023: Contracted to a large global pharma company as a Precision Medicine Project Manager. Provided project management support to cross-functional translational research teams and diagnostics teams, all within oncology translational research. • Implemented budget forecasting for multiple Translational Research teams in Planisware, enabling budget transparency and reconciliation. • Piloted new project plan template in Microsoft Project for detailed project planning across multiple clinical trials. • Partnered with translational research leaders, clinical teams, operations leaders, and subject matter experts to deliver and execute biomarker plans for global oncology clinical trials. • Lead teams to identify risks or issues affecting timelines and budgets. • Managed team communication and global project progress reporting for translational research projects spanning from early product development to late stage global oncology clinical trials across hematology, immuno-oncology, cell therapy, and solid tumor therapy programs. • Drove various initiatives within the Precision Medicine PM group to refine the PMed PM role and bring technology solutions to our stakeholders. Show less