Tara Shelton Email & Phone Number

Durham, North Carolina, United States

As a Director at Q2 Solutions, I collaborate with staff and senior management to develop performance standards, strategies, and objectives that enable our team to achieve quality results efficiently. I advocate for continuous process improvements and the development of a quality culture. I manage the resolution of challenges in operations, quality, safety, and supply chain efficiencies across multiple global laboratory locations. I am delighted to collaborate with talented and dedicated scientists who are at the forefront of innovation.

Durham, North Carolina, United States

As an associate director for global genomics operations, I lead a team of dedicated scientists that work to develop and manage analytical and pre-analytical laboratory services, supporting clinical trials with accurate and reproducible results delivered in a timely manner. I work closely with the global staff and department directors to establish and plan overall policies and goals that ensure the highest standards of quality and services are provided. My role includes resource management and the develop of innovative and sustainable solutions for global genomics project teams.

Raleigh-Durham, North Carolina Area

As a project manager for Q2 Solutions, I am dedicated to the development and the management of sponsor specific standards. I oversee global client portfolio management and the management of a global PM team. I serve as a liason between our sponsors and QLAB projects teams to facilitate communication, track timelines and milestones, monitor budgets, forecast resourcing needs, and work to ensure resolution of study related issues.

Raleigh-Durham, North Carolina Area

Effectively contributed to the discovery and development of drugs for global pharmaceutical leader; collaborated with colleagues in the US and the UK to achieve novel therapies in healthcare industry; coordinated and managed samples and analysis for multiple project teams, earned four recognition awards.• Extract biological samples for analysis by the use of turbulent flow chromatography, protein precipitation methods, and extraction of dried blood spots eliminating the need for expensive outsourcing contracts.• Develop and validate methods for sample analysis on LC/MS-MS providing solutions for the investigation of various chemical series.• Manage and maintain the operation of LC/MS-MS, proficient on Thermo TSQ Vantage/ Xcalibur and Micromass Quattro Ultima/MassLynx. Significantly reducing the delivery time for data compared to CRO contracts.• Execute plate based screening protocols in biology team effort to screen compounds using FLIPR and FLIPR Tetra; preparation of single point and DRC in 96 and 384 well format with ECHO liquid handler enabling the screen to progress by reducing the cost of the project. • Manage daily laboratory workflow of sample analysis on LC/MS-MS, data entry, review, and distribution in report form to project teams using Abase, IDBS and Report Writer consistently exceeding performance goals.• Report and distribute pharmacokinetic (PK) calculations obtained using Phoenix WinNonlin and Watson LIMS thereby providing critical data for human dose predictions.• Quality assurance (QA) review of data, standards, and quality controls (QC) adhering to best practices comparable to GLP guidelines.• Identify metabolites of advancing compounds.• Evaluate Biorelevant solubility over a range of pH values and simulated fluids decreasing research costs by characterizing solid properties earlier in the discovery process.• Prepare IND submissions to the FDA and investigational brochures.

Durham, North Carolina

Fulfilled an integral role in establishing Icagen as an industry leader in Ion Channel Technologies by building a bioanalytical portfolio of in house assays and services; effectively advanced drug discovery at Icagen by providing fast, reliable, and accurate data to project teams and collaborators worldwide; earned three promotions during tenure with Icagen (scientist II, III, and IV). Scientist III-IV•Tuned and operated LC/MS-MS for analysis and method development.•Managed daily laboratory workflow of sample analysis from LC/MS-MS, data entry, review, and distribution in report form. Consistently exceeded deadlines set forth in performance goals.•Calculated, reported and distributed pharmacokinetic (PK) calculations using Pharsight WinNonlin.•Tracked, organized, and archived raw data and reports. Adept at using Activity Base and Biobook for storage and distribution of data.•Prepared bioanalytical summaries for IND submissions to the FDA and investigational brochures in collaboration with the clinical group.Scientist I-II•Extracted in vivo study samples of blood, plasma, and tissue for analysis by LC/MS-MS.•Initiated, developed, and implemented in house ADME assays, including microsomal (LM), plasma, and metabolic stability, solubility, binding (PPB and BTB), inhibition (DDI and TDI), reaction phenotyping, and permeability (MDR-MDCK). In-house project development reduced outsourcing costs by 80% and simultaneously enabled more compounds to be screened for the projects.•Managed inventory of samples and laboratory supplies eliminating costly excess of analysis.

Durham, North Carolina

Associate Research ChemistKey Responsibilities•Extracted agricultural products and their analytes from soil samples in an effort to determine the environmental fate of the compound for review by the US EPA. Consistent quality data reduced analysis cost by eliminating reassessment of samples. •Performed analytical testing of extracts using HPLC, GC/MS, and TLC; prepared samples for analysis by LC/MS-MS. Perform data analysis of results from LC/MS-MS and HPLC, data entry and review.•GLP/GMP Certified