Crystal James
Newark
Summary
Analytical Chemist with a strong background in pharmaceutical development, currently serving as a Research Scientist in Technical Operations at Incyte. Brings extensive experience in analytical support for drug development, including data management in LIMS, standard management system oversight, and collaborative contributions across Process Chemistry, Formulation Development, QA, and Regulatory Affairs. Skilled in monitoring external lab activities, managing stability studies, and ensuring consistency in specifications and documentation for regulatory submissions. Committed to improving analytical systems and driving high-quality, timely deliverables that support the progression of pre-clinical, clinical, and commercial programs.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Research Scientist
Incyte
04.2022 - Current
- Perform analytical testing of drug substances and drug products using chromatographic and spectroscopic techniques (e.g., HPLC, GC, UV-Vis).
- Conduct method development, validation, and transfer activities in support of drug development.
- Lead solid-state characterization efforts including XRPD, DSC, TGA, and FTIR to evaluate polymorphism, thermal behavior, and material compatibility.
- Review and interpret analytical and solid-state data to ensure accuracy and regulatory compliance.
- Support stability studies by generating and compiling data, and ensuring data integrity.
- Author analytical method protocols, validation reports, technical documents, and regulatory submissions.
- Collaborate with cross-functional teams to troubleshoot analytical and material science challenges and ensure timely project progression.
- Maintain LIMS and manage data integrity practices in alignment with GMP requirements.
- Coordinate with external laboratories to oversee outsourced testing and ensure timely delivery of high-quality analytical and solid-state data.
Associate Investigator
Axalta
03.2018 - 03.2021
- Conduct chemical and physical analysis of raw materials, intermediates, and final products using a variety of analytical techniques (e.g., GC, HPLC, FTIR, UV-Vis, ICP, XRF, DSC, TGA).
- Develop and validate new analytical methods to support product development and quality control.
- Provide technical support and data interpretation to R&D chemists, process engineers, and manufacturing teams.
- Investigate product failures or customer complaints through root-cause analysis and recommend corrective actions.
- Maintain and troubleshoot analytical instrumentation to ensure optimal performance.
- Prepare technical reports, SOPs, and documentation in compliance with internal and regulatory standards.
- Ensure laboratory activities follow all applicable safety and environmental protocols.
Microbiology Professor/Consultant Grant Writer
Delaware Technical & Community College
08.2018 - 05.2020
- Delivered engaging lectures and laboratory instruction in microbiology, integrating advanced techniques such as Western blotting, immunohistochemistry (IHC), cryostat sectioning, PCR, ELISA, and aseptic bacterial culturing.
- Developed and aligned course materials with current scientific practices, mentoring students in scientific research and laboratory careers.
- Contributed to interdepartmental curriculum design and educational planning initiatives.
- Wrote, edited, and managed grant proposals, technical reports, and institutional documents for educational and research initiatives.
- Supported budgeting, project coordination, and inter-agency collaborations to advance institutional goals in STEM education and research.
- Designed and led grant writing workshops, edited research manuscripts, and created promotional materials to support outreach and dissemination efforts.
Research
University of Delaware
06.2015 - 06.2017
- Conducted interdisciplinary research focused on neurobiology, including the study of neurodegenerative mechanisms, neuroinflammation, and neural cell signaling.
- Utilized molecular biology techniques such as real-time PCR, RT-PCR, ELISA, Western blotting, IHC, and immunofluorescence to analyze gene and protein expression in neural tissues.
- Performed cryosectioning and imaging of brain tissue to investigate histological and cellular changes.
- Assisted in the design, execution, and analysis of behavioral assays in rodent models of neurological disease.
- Maintained detailed lab records, analyzed quantitative data, and contributed to scientific manuscripts and presentation
- Conducted marketing research resulting in 10 strong leads.
Education
Ph.D. - Neuroscience
Delaware State University
Dover, DE12-2025
Bachelor of Science - Biochemistry
University of Delaware
Newark, DE06-2018
Associate of Science - Chemistry
Delaware Technical Community College
Newark, DE06-2016
Skills
Analytical Chemistry:
- HPLC, GC, UV-Vis, FTIR, XRPD, DSC, TGA
- Method development, validation, and transfer
- Stability testing, impurity profiling, solid-state analysis
Molecular & Cell Biology:
- PCR, RT-PCR, qPCR, ELISA, Western blotting
- Immunohistochemistry (IHC), immunofluorescence
- Cryosectioning, microscopy, cell culture (mammalian)
Microbiology:
- Aseptic technique, bacterial culturing, plate streaking
- Soil and environmental sample analysis
- Antibiotic resistance screening, MALDI-TOF
Data Analysis & Software:
- MATLAB, Minitab, Igor, Avizo
- SAP, eLIMS, EDMS, Microsoft Office Suite
Research & Documentation:
- Grant writing and scientific reporting
- SOPs, technical protocols, regulatory documentation
- Statistical analysis, experimental design, data integrity practices
Accomplishments
- Authored and contributed to multiple successful regulatory submissions, including analytical method validations and technical protocols.
- Developed over 30 novel waterborne formulations at Axalta, several of which advanced to pilot production and commercialization.
- Managed federal and state grant submissions totaling over $1M in funding during tenure as Grant Assistant, supporting STEM education and research infrastructure.
LANGUAGES
Creole French
Native or Bilingual
Certification
- Waters Empower Software Training
- LIMS Certificate Training
Affiliations
- NOBCChE
- ACS
- AAPS
Timeline
Research Scientist
Incyte
04.2022 - Current
Microbiology Professor/Consultant Grant Writer
Delaware Technical & Community College
08.2018 - 05.2020
Associate Investigator
Axalta
03.2018 - 03.2021
Research
University of Delaware
06.2015 - 06.2017
Ph.D. - Neuroscience
Delaware State University
Bachelor of Science - Biochemistry
University of Delaware
Associate of Science - Chemistry
Delaware Technical Community College
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