Crystal James
Newark,DE
Summary
PhD-trained pharmaceutical scientist with 10+ years of scientific experience spanning preclinical neuroscience, analytical development, and regulated laboratory operations. Combines four years of hands-on in vivo research with pharmaceutical industry experience advancing drug substance and drug product programs. Leads analytical development activities, oversees stability studies across 20 projects, and manages operational readiness of 12 analytical instruments. Brings expertise in therapeutic efficacy assessment, cross-functional collaboration, vendor coordination, and scientific mentorship, translating complex data into actionable insights that guide development decisions and program execution.
Overview
1
1
Certification
11
11
years of professional experience
Work History
Research Scientist
Incyte
Wilmington, DE
03.2021 - Current
- Lead analytical method development, validation, and transfer for drug substance and drug product programs in R&D and GMP environments.
- Managed stability studies, protocols, and reports for 20 projects, ensuring compliance and quality standards.
- Partnered with cross-functional teams to resolve technical challenges, facilitating timely advancement of development timelines.
- Interpreted analytical data and authored technical and regulatory-support documentation to support project objectives.
- Oversee 12 analytical instruments, coordinating vendor maintenance, repairs, and troubleshooting.
- Maintain accurate, traceable laboratory records in LIMS and BIOVIA ELN.
Doctoral Researcher
Delaware State University
Dover, DE
09.2022 - 12.2025
- Led longitudinal studies evaluating therapeutic efficacy and disease progression in an α-synuclein mouse model of Parkinson’s disease.
- Designed randomized studies and conducted blinded behavioral assessments, integrating neurochemical, histological, and imaging endpoints.
- Executed animal dosing, health monitoring, blood collection, perfusion, necropsy, and brain tissue dissection to ensure the integrity of experimental data.
- Analyzed multidisciplinary datasets using GraphPad Prism and statistical methods to assess therapeutic response.
- Facilitated IACUC protocol compliance, streamlined procedures, and ensured accurate study records to support research integrity.
- Coordinated laboratory collaborations, trained researchers, and disseminated findings through publications and conference presentations to enhance research visibility.
Associate Investigator
Axalta
Philadelphia, PA
03.2018 - 03.2022
- Conducted analytical testing and developed methods to ensure product quality, enhance formulation development, and optimize processes.
- Characterized raw materials, intermediates, and finished products using chromatographic and spectroscopic techniques.
- Investigated product failures and supported root-cause analysis and corrective actions.
- Partnered with R&D, engineering, and manufacturing teams to troubleshoot product and process issues, facilitating successful scale-up.
- Created SOPs, technical reports, and validation documentation to meet safety, quality, and regulatory standards.
Instructor
Delaware Technical & Community College
Newark, DE
08.2018 - 05.2020
- Developed hands-on laboratory curricula integrating research techniques and applied learning.
- Mentored students in experimental design and laboratory methods, fostering skills in scientific reporting and critical thinking.
- Conducted interdisciplinary research and taught laboratory courses in microbiology and life sciences, enhancing student understanding and engagement.
- Supported grant-funded research through technical writing and data analysis, coordinating projects to advance research objectives.
Technician
DuPont
Newark, DE
06.2015 - 06.2017
- Performed routine and nonroutine analytical testing using HPLC, GC, UV-Vis, and FTIR to support research and product development.
- Maintained and calibrated analytical instruments, ensuring optimal performance for reliable test results.
- Prepared samples, standards, and reagents following established procedures to ensure accuracy in testing.
- Supported method development and troubleshooting, contributing to effective root-cause investigations.
- Analyzed and documented results in laboratory notebooks and electronic systems.
- Collaborated with research teams to meet project timelines while following laboratory safety and documentation requirements.
Education
Ph.D. -
Delaware State University
Dover, DE12-2025
Bachelor of Science - Biochemistry, Biological Science
University of Delaware
Newark, DE06-2018
Associate of Science - Chemistry, Biotechnology, Chemistry
Delaware Technical Community College
Newark, DE06-2016
Skills
Analytical development
Project stability oversight
GMP compliance
Statistical analysis
Translational Research
Data interpretation
Chromatography
Certification
- ISPE
- OSHA
- ICH Guidelines / Stability
- Data Integrity (ALCOA+)
- Labware LIMS Certificate Training
LANGUAGES
Creole French
Accomplishments
- Led the design and execution of longitudinal preclinical studies to assess therapeutic efficacy and disease progression in a rodent disease model.
- Integrated behavioral, neurochemical, histological, and imaging findings to guide research priorities and inform therapeutic evaluation.
- Strengthened study rigor and compliance through IACUC protocol development, procedural optimization, and researcher training.
Affiliations
- NOBCChE
- ACS
Timeline
Doctoral Researcher
Delaware State University
09.2022 - 12.2025
Research Scientist
Incyte
03.2021 - Current
Instructor
Delaware Technical & Community College
08.2018 - 05.2020
Associate Investigator
Axalta
03.2018 - 03.2022
Technician
DuPont
06.2015 - 06.2017
Ph.D. -
Delaware State University
Bachelor of Science - Biochemistry, Biological Science
University of Delaware
Associate of Science - Chemistry, Biotechnology, Chemistry
Delaware Technical Community College