Managed and implemented control strategy, ICH compliant stability protocols, trending analysis, and retest/expiry dating for a 12+ individual drug substance and drug product lots across 3 clinical phase Fc-fusion programs.Developed and managed transfer and qualification of 4 potency assays to contract laboratories to support release and stability testing for 2 clinical programs. Authored/reviewed/updated CMC filings and responses to global health authorities. Collaborated with CMC and regulatory to author product specifications and supporting documentation (Justification of Specifications and ranking/classification of critical product quality attributes).

Collaborated with executives, department leads, technical staff, and contracted resources to develop and implement analytical and control strategy for cancer vaccine-focused drug product pipeline.Elevated stability data reporting and trending analysis in accordance with ICH guidelines to support product characterization and expiration/retest date justification for a diverse portfolio of investigational drug products: viral vectors, protein antigens, and vaccine adjuvant.Oversaw contracted service providers and in-house QC laboratory, ensuring GMP compliance and timely delivery of release and stability test results for 10+ (clinical phase) APIs, drug substances, and drug product lots.Managed in house quality control laboratory, including 4 QC technicians in support of product specific release and stability testing.Executed potency assay transfer from Assay Development to QC laboratory, including assay qualification and integration into ongoing programs.

Led vendor qualification, selection and audits for contracted testing services and raw materials.Primary point of contact for regulatory agency audits (2 per year, DOH and Joint Commission); ensured and documented personnel qualifications and training, instrument maintenance, proficiency testing, and overall quality of laboratory systems and services.Conceived, developed, and directed all aspects of the development of an immunoassay (ELISA) production facility; employed Lean/Six Sigma principals that resulted in a reduction of consumable costs by ~$350,000 annually. Prioritized biomarker candidates, allocated resources, and directed development and validation studies that expanded commercial laboratory test menu resulting in $480,000 of new annual revenue.

Co-authored, managed submission and budget as the Principle Investigator for Small Business and Innovation Research award of $493,000 (indirect costs, 1R43NS065773).Delivered innovative lectures on neurospychopharmacology and pulmonary pharmacology to undergraduate and graduate classes. Led collaborative research projects with stake holders across multiple departments and institutions and employed cellular and molecular biology expertise that resulted in 9 publications and diversified funding sources.

Maintained and monitored laboratory (Chemistry and Hematology) procedures and personnel (40+) ensuring compliance with the College of American Pathologists, Joint Commission, Office of Safety and Health Affairs, Equal Employment Opportunity and Federal Civilian Personnel and the Department of the Army regulations. Improved R&D capability and GME mission by procuring and managing installation of $550,000 in new lab equipment; initiating and navigating the military (MRMC) application and procurement process.Originated and established research program to develop mouse embryonic stem cell-derived neurons as a model system for high-throughput testing of Botulinum neurotoxin countermeasures.