Steve Strawn Email and Phone Number
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• Scientist with over 20 years of experience with preclinical support for IND and BLA submissions for biologics and small molecules • Data management and statistical analysis for regulatory submission and publications, including pharmacokinetics and statistical analyses• Perform extensive In-vivo studies for regulatory submissions including toxicological, pharmacokinetic, efficacy and R&D studies
Omeros Corporation
View- Website:
- omeros.com
- Employees:
- 279
-
Senior Manager Qc StabilityOmeros Corporation Jun 2023 - Present
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Qc ManagerNovavax Inc Feb 2022 - Jun 2023Gaithersburg, Maryland, United StatesManage 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 -
ManagerMeso Scale Diagnostics, Llc. Jan 2021 - Feb 2022Rockville, Maryland, United StatesManage 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 -
Research ScientistPrometic Bioproduction & Biotherapeutics Sep 2015 - Jan 2021Manage 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 -
Lab ManagerGeorgetown University Jul 2010 - Sep 2015Washington D.C. Metro AreaManaged 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 -
Associate ScientistChampions Oncology, Inc. Apr 2009 - Jul 2010Managed 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 -
Research AssociateEntremed May 2004 - Dec 2008 -
Research AssociateHuman Genome Sciences Aug 1997 - Dec 2003
Steve Strawn Skills
Steve Strawn Education Details
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Master'S Degree
Frequently Asked Questions about Steve Strawn
What company does Steve Strawn work for?
Steve Strawn works for Omeros Corporation
What is Steve Strawn's role at the current company?
Steve Strawn's current role is Senior Manager Quality Control.
What is Steve Strawn's email address?
Steve Strawn's email address is ss****@****vax.com
What schools did Steve Strawn attend?
Steve Strawn attended Virginia Tech, Radford University.
What skills is Steve Strawn known for?
Steve Strawn has skills like Lifesciences, Biotechnology, Cell Culture, Molecular Biology, Assay Development, Life Sciences, Pharmaceutical Industry, Research, Immunology, Pcr, Glp, Drug Discovery.
Who are Steve Strawn's colleagues?
Steve Strawn's colleagues are Betsy Moore, Tina Quinton, Lauren Berndt Hamilton, Ethan Schwendeman, Brian Parent, Jessica Dorny, Jason Hargett.
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