Experience

Orion Therapeutics Inc.
• United States
• Biotechnology Research
• 1 - 100 Employee
• President and CEO

  • Mar 2022 - Present


Self-employed

• Real Estate
• 1 - 100 Employee

• Private Consultant

  • Aug 2021 - Present

  Private Consulting Services: Liposome and LNP Technology: Formulation Development and Optimization, Analytical Method Development, cGMP guidelines and regulatory support (e.g. integrate QMS), Quality-by-Design (QbD) drug development strategies, DoE process/formulation optimization, sterile filtration and fill and finish support, drug discovery support, immunoassay development, preclinical development (in vitro and in vivo), IND-enabling study and CMC support, ligand conjugation and lipid chemistry support, liposome and LNP binding assay support, structure-activity relationship (SAR) study support, clinical trial support Show less



T&T Scientific Corporation

• Director of Formulation

  • May 2019 - Aug 2021

  Job Overview: The Director of Formulation oversees all CRO activities in conjunction with the Chief Technology Officer and President. This position is responsible for LNP preparation and synthesis, formulation process development, analytical method development, process scale-up and transfer to GMP facilities, and development of scale-down models. Job Functions: • Oversees all CRO activities in conjunction with Chief Technology Officer and President of T&T • Assists with development and analytical characterization of biotherapeutic modalities including lipid nanoparticles, polymeric nanoparticles, vaccines, and protein-based therapies. • Performs analytical methods including, but not limited to, HPLC, DLS, GC/MS, and UV/Vis and Fluorescent spectrophotometry. • Performs hands-on experimentation towards the preparation of innovative drug delivery solutions including, but not limited to, lipids for use in nanoparticles for early research studies. • Plans CRO project-related scientific and technical activities. • Utilize chromatographic, biophysical and other analytical methods for characterization in order to fully understand quality attributes of drug products. • Manage laboratory, including care and upkeep of complex lab instrumentation, oversight of important reagent/sample inventory. • Write and present organized data analysis and interpretation via technical reports. • Data management including notebook keeping, processing of data, writing reports on projects and presenting results of team members. • Write/Develop quality procedures, test methods, and standard operating procedures. • Adheres to cGMP work practices and works closely with the Quality organization to ensure strict compliance with applicable GMP procedures and compliance requirements • Conduct laboratory studies based on DoE as needed, for formulation optimization and stability confirmation • Participate in design and development of solvent injection technologies. Show less



The University of Tennessee Graduate School of Medicine

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Research Associate III

  • Aug 2011 - May 2019

  Job Location: This job was performed in the Vascular Research Lab (VRL) located at The University of Tennessee Medical Center. The VRL was sponsored by the Vascular Gift Fund within the Department of Vascular Surgery. Our research was focused on the development of gene therapy applications for the prevention of atherosclerosis and neointimal hyperplasia in a surgical model. Job Summary: The Research Associate III designs and conducts research projects, analyzes and presents data, executes procedures for in vivo and in vitro studies under GLP guidelines, and trains/surpervises designated personnel, residents, and physicians as part of the vascular surgery fellowship program. Job Functions: Exercises independent judgment in planning, design, conduct, data collection, analysis, interpretation, and presentation of research data; as necessary makes changes to experiments. Confers with principal investigator in developing plans for research projects; plans, develops, and implements specialized techniques and analytical procedures. Coordinates and/or directs the work of subordinate research personnel. Proceeds from a theoretical framework and may participate in the design of human subjects intervention. Participates in the intervention including recommending modifications as the study proceeds. May function as the supervisor in an intervention. Prepares detailed reports on research results. Operates technical laboratory instruments. Instructs, trains, and supervises other research personnel. Performs other duties as assigned. Show less



Sandvik

• Sweden
• Mining
• 700 & Above Employee

• Quality Department Specialist

  • May 2009 - Aug 2010

  Oversaw supplier audits and supplier approval procedures as it pertains to ISO 9001 and ISO 13485 quality procedures in the medical device manufacturing industry. Oversaw supplier audits and supplier approval procedures as it pertains to ISO 9001 and ISO 13485 quality procedures in the medical device manufacturing industry.