Brian Smith Email & Phone Number

Kansas City, Mo, Us

Luxembourg, Luxembourg, Lu

Oversee daily operations including laboratory, quality, logistic, and managerial duties as site leader. Responsible for the supervision, organization, and coordination of all technical and operational activities of the Eurofins bioanalytical laboratory.

Dublin, Ie

Lead teams within the Lenexa Bioanalyical Laboratory at ICON plc (formerly PRA Health Sciences). Responsible for the daily operations and quality of teams tasked with the project management, analysis and reporting of clinical study analysis across all phases of development in a GLP/GCP (GxP) environment.

Dublin, Oh, Us

Lead Scientific Writing team within the Regulatory Sciences Division of Cardinal Health. Member of the Executive Committee Leadership Team. Responsible for the daily operations of a team tasked with preparing GLP, GCP and GMP regulatory documents for discovery, preclinical research, IND applications, Phase 1–3 study conduct, clinical study protocols and reports, integration of efficacy and safety clinical data for submission of a NDA or BLA to FDA and/or other global regulatory agencies, and the conduct of formalized post-marketing research (Phase 4).

Durham, North Carolina, Us

Responsible for overseeing multiple disciplines and functional areas of the GCP Lab Operations organization. Ensure that laboratory operations meet or exceed all applicable regulatory requirements. Collaborate with Quality Assurance staff to develop and implement effective programs. Participate in the development and implementation of the department's operating budget, vendor management/qualification and daily operations. Member of Early Clinical Development Leadership Team.

Kansas City, Ks, Us

Member of Executive Management Team. Manage core service groups and supervise departmental managers including Enzyme Induction Dept., Enzyme Inhibition Dept., Drug Metabolism Dept., Drug Transport Dept., Knowledge Management Dept., Analytical Services Dept. and Technology Service and Development Dept. Serve as XenoTech Management and scientific reviewer on multiple nonclinical drug interaction-related contract studies.

Kansas City, Ks, Us

Serve as management for multiple GLP nonclinical, drug interaction-related contract studies . Job responsibilities include overall department management, designing, scheduling, and supervising protocol driven studies, research and development projects, reviewing data, responding to sponsor and in-house Quality Assurance audit reports, maintaining correspondence with sponsors and publication quality reports for contract studies. Management responsibilities include management of the Enzyme Inhibition Service Department which consists of six other individuals. Maintain supervisory roles for one Principal Scientist, one Senior Scientist and four analysts (Scientist I-III).

Dr. Emily Scott's group: Management of daily laboratory operations for an academic laboratory. Responsible for initiating and leading projects that include Cytochrome P450 recombinant engineering, protein purification, protein crystallization, and metabolism and binding assays. Students followed protocols that I wrote and optimized.

Perform drug extractions from client samples for confirming use of illicit drugs by GCMS. Responsible for solution preparation and laboratory maintenance. Responsible for daily quality control as well as head of quality assurance for the laboratory.

Administration of immuno-assay testing of client samples for confirming illicit drug use and detection of disease. Responsible for solution preparation and laboratory maintenance including quality control. Head of quality assurance program for the laboratory.