Dakota Ward, PhD
Graham,NC
Summary
Highly motivated and detail-oriented scientist with experience leading analytical and bioanalytical projects ranging from method development to commercialization in CGMP, GLP and GCP environments. Educated in processes and regulations according to ICH and FDA guidelines. Proven ability to absorb information quickly and apply new concepts with a high level of professional integrity. Adept at producing peak-quality results independently or in team-oriented settings. Pursuing role and leveraging exceptional technical knowledge to better satisfy customer needs.
Overview
5
5
years of professional experience
Work History
Scientist II, Analytical Development
Recipharm Laboratories, Inc
10.2021 - Current
- Work independently with advanced equipment such as HPLC, LC/MS, FTIR, and particle size equipment and appropriately analyze associated data
- Manage and execute method validations, method transfers, and compendial verifications for product characterization
- Training and mentoring department as subject matter expert (SME) on various instruments, method techniques, and softwares
- Author and review protocols, reports, COAs, SOPs, and other CGMP documentation as requires at a high-quality level
- Author, revise, and/or review test methods, training materials, and other procedures base on high level of experience and knowledge of technical principles
- Analyze aberrant data/performance and independently troubleshoot and maintain instrumentation to reduce downtime
- Participate in and/or author deviations, laboratory investigations, invalid data events, root cause analyses, change controls, CAPAs, and other Quality System procedures as required
Scientist I, Analytical and Formulation Sciences
KBI Biopharma, Inc.
10.2020 - 10.2021
- Lead scientist on various analytical projects with particular expertise in method qualification and validation
- Project lead and lead scientist on various large molecule pre-formulation studies including solubility, surfactant screening, DoE, and stability studies
- Performed routine CGMP testing for the release and stability clinical and market products
- Development of various LC, FTIR, and bioassay methods
- Independently authored analytical testing methods, study plans, protocols, reports, and certificates of analysis/testing following CGMP guidelines and federal regulations
- Subject Matter Expert (SME) and Qualified Trainer (QT) for plate-based assays including Potency by ELISA and quantitation of manufacturing biomarkers
- Headed the CSV of GxP SoftMax Pro V7.1.1.
Scientist I, Bioanalytical Operations
BioAgilytix Labs, LLC
06.2019 - 08.2020
- Lead scientist on various biomarker, pharmacokinetic, and anti-drug antibody (ADA) projects
- Development of plate-based (ELISA/ECL) assays involving antibody labeling and assay optimization in a Fit-for-Purpose model
- Led plate-based (ELISA/ECL) pre-clinical and clinical sample analysis studies including sample management and preparation, assay execution, and data analysis under CGLP/GCP guidelines
- Independently authored study plans, protocols, and reports for qualification, validation, and preclinical and clinical sample analysis projects under CGLP/GCP guidelines
- Managed project timelines and maintained accurate inventories of supplies for laboratory needs and forecasted future needs based on anticipated project needs
- Qualified trainer (QT) of analysts and scientists in various facets including Watson LIMS and BioTek Gen5.
Education
Ph.D. - Biomedical Research
Marshall University
HUNTINGTON, WV06.2019
Bachelor of Science - Biochemistry
Marshall University
HUNTINGTON, WV12.2013
Skills
- Analytical Method Development, Qualification, and Validation
- Experience in CGMP, GLP Manufacturing, and GCP Environments
- SME on LC, Spectroscopy, and Various Plate-Based Techniques
- Risk Assessment and Hazardous Compound Handling and Control Specialist
- Author of CGMP and Quality System Documentation
- Qualified Trainer
Techniques and Software
- High/Ultra Performance Liquid Chromatography (Agilent 1100/1200/1260-series, Shimadzu 20/30/40-Series, Waters ACQUITY) including methods for SEC, IEX/AEX/CEX, ELSD, and CAD
- Sciex PA 800 Plus for capillary electrophoresis and isoelectric focusing
- Agilent Cary 60, CTech SoloVPE, Biotools FTIR, Shimadzu IRAffinity-1S FTIR, and Jasco J-1000 Circular Dichroism
- Dynamic Shear Rheometry - Anton Paar
- Empower 3 FR5, Open Lab CDS, Gen5, SoftMax Pro, GraphPad Prism, SigmaStat, ImageLab, ChemDraw, Watson LIMS, LabWare LIMS, ZenQMS, Workplace, Workday, WorkFront, NetSuite, Microsoft Office
Publications
Available Upon Request: https://pubmed.ncbi.nlm.nih.gov/?term=dakota+ward
Timeline
Scientist II, Analytical Development
Recipharm Laboratories, Inc
10.2021 - Current
Scientist I, Analytical and Formulation Sciences
KBI Biopharma, Inc.
10.2020 - 10.2021
Scientist I, Bioanalytical Operations
BioAgilytix Labs, LLC
06.2019 - 08.2020
Ph.D. - Biomedical Research
Marshall University
Bachelor of Science - Biochemistry
Marshall University
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