Dr. Schoukroun-Barnes is a PMI-certified Program Management Professional (PMP), Regulatory Affairs certified (RAC), and an APICS-certified (CSCP) project manager. She has eight years of experience managing and supporting projects, including product development for vaccines, cell and gene therapies, medical countermeasure therapeutics, medical devices, and diagnostics.
Dr. Schoukroun-Barnes brings a wealth of knowledge to LBG and leads and supports multiple commercial and government programs, their planning, and their successful delivery. She leads and assists with the management of the day-to-day aspects of projects and provides technical support, reviews new life sciences products and technologies, and assists with internal and external business development efforts. In addition, she has experience in the management and preparation of regulatory submissions to multiple regulatory authorities, including FDA, EMA, and MHRA, and has managed and authored technical aspects of pre-INDs, INDs, and clinical trial documents.
Specifically, Dr. Schoukroun-Barnes focuses on the development and review of all aspects of INDs with capabilities in the authoring of regional specific information (Module 1), CMC (Module 3), and Clinical (Module 5) documents in support of vaccine and biologic-related products. She also has demonstrated abilities to author pre-EUA, EUA, and Q-submissions as they relate to medical devices, and she continues to grow her knowledge and capabilities beyond U.S. FDA regulatory interactions.
Dr. Schoukroun-Barnes is well versed in the preparation of government technical and business proposals for non-dilutive funding and has led proposals that have successfully received up to $45 million in funding. She has managed and independently submitted government proposals to several agencies, including DTRA, BARDA, NIAID, and the U.S. Air Force, among others. She has also provided support in contract negotiations and post-award programmatic management in both technical and budgetary areas.
Dr. Schoukroun-Barnes started her career as an analytical chemist and has extensive research experience in bioanalytical sensor fabrication and utilization, specifically for the monitoring of small molecule targets directly in biological matrices. She started her industry career at a small molecule CDMO, where she worked in an FDA and MHRA-regulated cGMP laboratory environment, conducting validation studies and completing tests for finished drug products (assay, impurity, and preservative methodologies) and samples (stability and release). She is proficient in several laboratory software platforms and analytical and electrochemical methodologies.
In addition, Dr. Schoukroun-Barnes has experience at a large molecule CDMO, where she supported the technical submission of proposal responses to RFP requests for non-cGMP and cGMP drug substance manufacturing. As a result, she has extensive experience leading teams that include technical and business-oriented personnel. She has also published several peer-reviewed scientific and business-geared articles in various journals and presented her research at industry conferences.
Dr. Schoukroun-Barnes received her B.S. in Chemistry from Mount St. Mary’s University and her Ph.D. in Analytical Chemistry from the University of Maryland, Baltimore County.
