STEVEN KANE

SUMMARY

Analytical minded leader with proven abilities to build relationships with internal and external customers by establishing trust, confidence and transparency through analysis and effective communication. Very strong aptitude to quickly solve problems as they arise and manage multiple tasks with extreme attention to detail obtained through experience in FDA regulated laboratories, medical research projects and stability study project management.

EXPERIENCE

Baxter Healthcare Round Lake, IL Jan 2014-Current

Research Associate II/III – Exploratory Research/Commercial Stability Analyst

Contributed to a small team tasked with consistently meeting deadlines for chemical testing, report generation, and review of laboratory data ensuring product is acceptable for human consumption and meets all FDA regulations.

•Daily cross-functional collaboration with Process Engineering, Manufacturing, Regulatory, Method Development/Validation, Quality Assurance, and Exploratory Research groups.

•Project Coordinator/Manager of 10+ Drug Development projects from project initiation through completion including Sharepoint/PRIME/MS Project, Data/Document management, and ensuring regulatory compliance of the project.

•Provided training, technical expertise, and managed results for 10+ short-term and 100+ long-term Commercial Stability, Preclinical through Phase 3 Clinical studies, and Exploratory Research studies per month.

•Lead Project Coordinator and Subject Matter Expert (SME) for utilization of metrohm equipment, flame photometer, graphite furnace, and multiple HPLC methods.

•Participated in the Optimize Reformulation project as Lead Stability Analyst with the Method Validation/Development and Manufacturing groups.

•Participated on Medical Products Global Expansion project as the Stability Analytical Lead. Responsible for daily interaction with team members in India and Belgium in order to streamline global testing procedures and data handling.

•Participated in implementation of the In-Line Mixer Project with the Process Engineering and Manufacturing groups as the Project Analytical Expert.

•Participated in 6S Medical Products Process Improvement Initiative involving 3 laboratories as a 6S Champion.

•Authored multiple protocols, authored and compiled data reports, and managed workload for multiple Process Engineering and Product Development projects on a monthly basis.

Abbott Laboratories/Abbvie North Chicago, IL Jan 2012 – Dec 2013

Chemist II/III – In-Production/Finished Goods Lead Analyst

Contributed to a group tasked with timely chemical testing, data analysis, and report generation for raw materials, intermediary compounds, and finished pharmaceutical drugs in preparation for final product manufacture.

•Initiated and authored multiple method and control change documents in support of multiple Research and Development projects.

•Produced data for 30+ pharmaceutical precursors, intermediate compounds, and active pharmaceutical ingredients utilizing a wide variety of analytical techniques on a weekly basis.

•Subject Matter Expert for metrohm equipment, heavy metals, FTIR, and multiple HPLC methods. Responsible for ensuring training of analysts, troubleshooting, system maintenance, and archival of data.

•Daily cross-functional collaboration with Global R&D, Method Validation/Development, Supply Chain, Project Management, Regulatory, and In-Process/Manufacturing groups.

•Obtained and compiled reports of analytical results for multiple FDA filings and R&D projects.

University of Michigan Ann Arbor, MI Jan 2010 – Dec 2011

Exploratory Research Associate – Immunology

Immediate assistant to postdoctoral fellow responsible for the conception of research projects, gathering of data, authoring grants, and authoring research papers for publication in medical research journals.

•Authored and published 3 medical research papers using self-generated and collaborative data.

•Authored and controlled multiple testing and production protocols for use in clinical and research studies.

•Performed in-vitro and in-vivo protein determination techniques to obtain publishable quality data.

•Responsible for the management and maintenance of multiple laboratory animal colonies (mouse and rat).

•Authored multiple model animal surgical procedures, experiment design protocols, instrument methods, and data/sample handling protocols used across 3 independent research groups.

University of Michigan Ann Arbor, MI Jun 2007 – Dec 2009

Undergraduate Asst. in Research

Contributed as part of a small core of employees tasked with the design, production, storage, and shipping of high purity viral vectors created to produce large quantities of protein from customer provided DNA for medical and industrial research.

•Contributed to the design of multiple viral templates across 3 viral vectors families (MMLV, Lenti, Adeno).

•Authored and maintained multiple protocols for viral production, safety, and storage.

•Managed viral production schedules and cell colonies for multiple clients concurrently.

•Managed allocated budget for viral production, storage, and shipping.

•Responsible for national and international sales and shipping.

SKILLS

Microsoft Office Suite

Adobe Reader

Empower 2 and 3

SQL Lims

Project Management (Initiation/overview/completion)

iLims/ ThermoLims

ISI Writer

Sharepoint creation/maintenance

Documentation control/review

RAC (Oct-Dec 2016)

EDUCATION

University of Michigan Ann Arbor, MI

Bachelor of Science, Biochemistry

Bachelor of Science, Chemistry

PUBLISHED PAPERS

1.Marques, MM, Campos, MRM, Kane, S., Rangel, AP, Ballinger, MN., Sang-Honn Kim, Peters-Golden, M, Jancar, S and Serezani, C.H. Leukotrienes target F-actin/cofilin-1 to enhance alveolar macrophage anti-fungal activity. J. Biol. Chem. 2011; 286(33):28902-13

2.Serezani, CH, Kane, S, Medeiros AI, Kim, SH, Lee, S, Lewis, C, Bourdonnay, E, Ballinger, M., Peters-Golden, M. PTEN Activates the Actin Depolymerization Factor Cofilin-1 During PGE2-Mediated Inhibition of Fungal Phagocytosis. Sci Signal. 2012 Feb 7; 5(210): ra12

3.Serezani, C.H., Kane, S., Collins, L., Morato-Marques, M, Osterholzer, J.J., Peters-Golden, M. Macrophage dectin-1 expression is controlled by leukotriene B4 via a GM-CSF/PU.1 axis. J Immunol. 2012 Jul 15; 189(2): 906-915

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