Brian Stamos Email & Phone Number

Cambridge, Massachusetts, United States

• Develop and implement forward looking CMC (Chemistry, Manufacturing, and Control) strategy for successful delivery of early stage IND enabling material• Evaluate, select, develop, and maintain relationships with CDMOs/CROs to supply phase appropriate material for clinical trials• Collaborate with internal stakeholders including quality, regulatory, clinical supply, program management, finance, and legal departments• Represent CMC at cross functional clinical development team meetings with senior leadership in attendance• Strategy and management of internal and external analytical strategy, from development to implementation for control, release, and stability• Authorship and maintenance of IND/IMPD/DSUR/IB CMC sections in collaboration with regulatory CMC• Provide responses to global health regulatory agency queries in alignment with regulatory, quality, and function specific groups

Greater Chicago Area

• Core team member of new product development programs to manage the analytical lifecycle from feasibility to launch• Deep understanding of regulatory requirements of the analytical lifecycle, and shaping future guidance• Development and Leadership of complete Excipient/Drug Substance/Drug Product validation packages tailored for regulatory submissions worldwide• Over 100 developed, validated, and transferred methods • Rapid hiring and on-boarding of new analytical resources, from fresh graduates to skilled analysts, to meet business needs• Innovation and implementation of new technologies to reduce costs by $250k+/year• Management of external partners, CROs, and CMOs with process improvements to reduce labor costs by over 15%• Fostering relationships to break down silos and promote collaboration across business units and cultures• Technical justifications in response to regulatory feedback, both pre and post filing Skills• Method Validation: Assay of DS/DP/Excipients, Related Substances/Impurities, Limit Tests, Identification• Instrumentation: Variety of LC/GC coupled Mass Spectrometers, HPLCs and UHPLCs with common and uncommon detectors, and basic instrumentation for characterization• Chromatography Data Systems and Analysis Packages: Empower, MassHunter, Chromeleon, MassLynx, UNIFI, Excalibur, Chemstation, Analyst• Software Development/Programming: LabView, PSoC Creator, C++, Python

Arlington, Tx

• Fully funded through research grants for entire tenure of graduate school• Creation of a portable, low power, low weight liquid chromatograph for spaceflight missions to Mars, with successful field testing in the Atacama Desert of Chilé• Designed, developed, built and patented method for whole column detection platform, including all hardware and control software• Development of automation tools for analysis of complex data sets generated from custom developed hardware

Arlington, Tx

• Worked in an interdisciplinary environment to develop and execute new strategies in proteomics research through collaborative effort. • Coordinated and trained new graduate/undergraduate students and taught problem solving techniques in instrumentation. • Participated heavily in initial lab setup, continuing a role in the maintenance of equipment and ordering of essential materials. • Analyzed proteins and organic/inorganic compounds with a number of analytical tools including GC, HPLC, NMR, FTIR, MALDI-TOF-MS, and UV/Vis spectrometry. • Constructed several genetic constructs, from cloning to mutagenesis to expression and purification of proteins on a scale of 1-100 mg with techniques in ion affinity chromatography and size exclusion chromatography. • Fine-tuned purification protocols for a wide variety of proteins, including unique protein constructs incorporated with unnatural amino acids. • Developed assays for the measurement of catalytic activity of multiple proteins both in vivo and in vitro.

Greenbelt, Md

• Development of proprietary ESI-MS inlet for low atmosphere and vacuum operation• Design, manufacturing, and implementation of electronic circuitry to measure nA level current at 3+ kV level potentials • Proof of concept of microchip fluidic cells for the separation of chiral amino acids and other small molecules using MS

Doctor Of Philosophy (Phd), Analytical Chemistry

Bachelor Of Science (B.S.), Analytical Chemistry

Bachelor Of Science (B.S.), Biochemistry