Steve Strawn Email & Phone Number

Gaithersburg, Maryland, United States

Manage QC Stability for COVID-19 Vaccine Program• Manage QC team under EUA conducting monthly stability submissions across multiple health authorities, including shelf-life extensions, and health authority responses• Direct authoring of quality documents including change controls, deviations, and CAPAs• Supervise work of external laboratories chambering and testing stability samples• Manage the transition from CMOs to on-site stability program• Develop analytic methods for stability evaluation and shelf-life extension using JMP

Rockville, Maryland, United States

Manage the development and validation of customer-based custom immunoassays on the MSD platform• Managed team of 6 scientists developing novel custom immunoassays for customers• Managed budget, schedule, personnel, and timelines across multiple projects• Ensured completion of assay development under strict budget and timelines• Routinely interface with customers to communicate data and project development

Manage BLA-directed preclinical and stability programs for human-derived plasma therapeutics, and prepare regulatory submissions● Developed ICH stability program to assess various plasma-derived protein therapeutics, including forced degradation studies to establish stability indicating assays● Trended stability and release data for statistical analyses and summarized for regulatory submissions using JMP and other analysis software● Authored BLA and IND supporting documents and reports for inclusion in regulatory filings, including interim and final reports, SOPs, and deviations● Managed preclinical in-vivo toxicological and release testing for BLA-directed studies● Directed and executed research, including the development and implementation of experimental protocols internally and with CROs● Established pharmacokinetic studies with external contractors, analyzed data using WinNonLin, and prepared reports for regulatory submission

Washington D.C. Metro Area

Managed federally funded grant-based research in the area of radiobiology, tumorigenesis, andmetabolomics for NASA, NIAID, NCI, NIEHS, and NIAAA● Developed and executed in vivo studies of radiation injury to support grant-driven research● Created protocols for regulatory approval from EHS, Radiation Safety, and IACUC● Developed and ran studies evaluating the effects of alcohol consumption in susceptibletransgenic mice● Supervised laboratory technical staff and students

Managed program to evaluate anticancer agents in human biopsies to instruct personalized cancercare● Patient liaison for tumor tissue acquisition from the surgical theater● Implanted primary patient tumors in immunocompromised mice, and propagated tumorssurgically in mice for testing with novel cancer therapeutics● Employed data from tumor model to facilitate generation of a searchable database of biopsysamples, tumor characteristics, and responsiveness to therapeutic agents● Established and managed a new laboratory facility for development of human tumorgrafts

Education record

Master'S Degree