Design and execute studies to evaluate the impact of preanalytical variables

(including blood collection, shipping, and storage conditions) on sample

integrity and analyte stability

Optimize sample collection, transportation, and processing workflows, including

selecting blood collection devices, identifying optimal shipping conditions and

sample collection kits

Identify, evaluate, and integrate new sample collection, fractionation, and

characterization technologies into preanalytical workflows

Work cross-functionally with internal teams (Program Management, Clinical

Operations, Regulatory, Quality) and external vendors to plan and execute

Development studies

Collaborate with Computational Biologists and Biostatisticians to define data

analysis approaches for Development studies

Mentor junior Scientists and Research Associates in the Preanalytical

Development team in the design and execution of Development studies

Responsible for characterizing the impact of preanalytical variables on Freenome’s multiomic tests and establishing robust, standardized protocols to improve preanalytical workflows. Executing at the bench as a subject matter expert in preanalytics as well as contributing to leveraging preanalytical datasets to generate biological insights that directly inform Freenome’s biomarker discovery studies and product development efforts. Collaborates with the Clinical Development, Lab Operations, and Computational Research teams to ensure that preanalytical considerations are represented in every aspect of Freenome’s research platform and product development.

Reviewed relevant literature, data, and on-market product to provide a comprehensive approach to new product development.

Conceptualized and assessed product solutions that addressed unmet user needs by evaluating market segmentation research and conducting competitive intelligence, which translated to product development lab work, including the development of benchtop prototypes, stability testing, and coordinating pilot plant/commercial scale-up trials. Worked closely with Supply Chain and Quality to evaluate, plan, and begin to execute the launch of product renovations as well as new products. Improved stability testing on existing products and helped in the transition to, and qualification of, a new manufacturing facility. Recommend and implemented changes for the continuous improvement of existing products. Presented research and plans for products to the Board of Directors and found a formulation change that improved cost of goods by 14%.

Researched immunogenicity of live and killed bacteria and their constituent antigens as well as developed assays to test their potency and efficacy both as challenges and as vaccines. Designed, implemented, and then statistically analyzed data from vaccine efficacy trials both in vivo and in vitro, before writing the findings into reports for regulatory agencies. Utilized murine, ovine, as well as rodent models and developed assays using tools such as HPLC, Flow Cytometry, ELISA, protein separation, purification, and quantification. Much of the research dealt with monoclonal and polyclonal antibodies and their development, titer, and efficacy in the face of a challenge. Harvested organs from research animals and assisted in all steps of the manufacture of vaccines. Wrote and updated standard operating procedures (SOP) for both research and development and quality. Hired, trained, and mentored interns and junior scientists, educated them in the development of in vitro diagnostics (IVD) used in verification and validation (V&V) studies as well as in statistical analysis which was performed in Excel and R. Facilitated the transition of the laboratory from BSL-1 to BSL-2.