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Work Background
Britt & ShepherdDirector of Acquisitions
Aug. 2023•Developed analytical tools for evaluating commercial real estate properties for medical and health sciences related office and laboratory utilization. •Provided input for laboratory and office layout design or changes based on the needs of the tenant.
•Evaluated value add commercial real estate opportunities for retail and low income housing projects.
Bristol-Myers SquibbAssociate Director
Apr. 2019 - Aug. 2023•Developed strategies to meet the demand of the overall biomarker assay support for a large challenging and diverse portfolio. •Provided scientific and technical oversight to scientists through the development, validation and implementation of fit-for-purpose biomarker assays for the analysis of clinical samples in a GxP environment or assays contracted to CROs. •Harmonized and implemented new processes across the large molecule and small molecule groups that resulted in a 50% reduction in audit findings per study. Additionally, under my leadership, an audit of a GLP study yielded no audit findings for the first time in the department’s history and incidents requiring data recall were diminished to 1 recall out of 184 studies over a 5 year period.
•Led the Study Support and Compliance group that focused on regulated analysis, compliance risk mitigation, and risk mitigation for BMS’s most technically challenging assets and critical assay types by establishing internal expertise prior to outsourcing.
•Designed and executed a risk based compliance strategy within Bioanalytical Sciences to ensure compliance with evolving Health Authority and industry standards for data integrity, 21 CFR Part 11, and Part 58.
•Served as the bioanalytical or biomarker SME for cardiovascular, oncology, and immuno-oncology programs to ensure data for regulatory filings was accurate, precise, and reproducible.
Bristol-Myers SquibbGroup Leader
Dec. 2017 - Apr. 2019
Bristol-Myers SquibbSr. Research Investigator II
Jun. 2015 - Dec. 2017Lawrenceville, New Jersey
Bristol-Myers SquibbSr. Research Investigator I
Oct. 2013 - Jun. 2015Lawrenceville, New Jersey
Bristol-Myers SquibbResearch Investigator II
Aug. 2011 - Oct. 2013Lawrenceville, NJ
PPDSenior Research Scientist
Apr. 2011 - Aug. 2011Bristol-Myers Squibb in Lawrenceville, NJ•Contributed to the validation and implementation of immunoassays for the analysis of nonclinical and clinical PK, immunogenicity, and biomarker samples in discovery and regulated environment (GLP and clinical).
•Communicated laboratory results in cross-disciplinary project team, department meetings, and reports. Contributed to the preparation and presentation of scientific material at internal meetings.
Tandem Labs (A LabCorp Company)Project Manager
Jun. 2009 - Apr. 2011•Scientific and project management oversight for the development and validation of pharmacokinetic (PK), immunogenicity (IMG), and neutralizing antibody (NAB) assays using electrochemiluminescent technology (ECL), ELISA, fluorescence and cell-based assays. Assays were used for the analysis of clinical and non-clinical samples in a GLP laboratory.
•Led a project management team of up to three people and directed the daily activities of up to 9 laboratory scientists while managing multiple (30+) development, validation, and production projects. In addition, worked closely with clients to complete Health Authority queries and post-marketing requirements (PMR).
Huntingdon Life SciencesStudy Manager
Nov. 2008 - Jun. 2009•Developed, validated, and conducted troubleshooting for ELISAs and enzyme kinetic methods for the detection of drugs and/or antibodies in clinical and non-clinical samples.
•Analyzed clinical and non-clinical study samples in compliance with SOPs and Good Laboratory Practice (GLP) and answered internal and external Quality Assurance study audits.
Huntingdon Life SciencesResearch Scientist
Oct. 2007 - Nov. 2008
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