NAOMI SWEDER GOLD
Clarksburg,MD
Summary
Accomplished Computational Toxicologist with extensive experience as an FDA contractor, specializing in computational toxicology assessments and nitrosamine impurities. Demonstrates expertise in QSAR methodology and cheminformatics, successfully optimizing workflows and training teams. Proven success in enhancing regulatory compliance standards while leading impactful public education initiatives.
Overview
3
3
years of professional experience
Work History
Computational Toxicologist
FDA Contractor
Silver Spring, USA
01.2022 - Current
- Consulted on computational toxicology assessments for various endpoints for internal stakeholders at FDA/CDER.
- Drafted reports detailing the results of toxicological investigations and analyses.
- Conducted CPCA assessments of small molecules and nitrosamine drug-related impurities (NDSRIs) for the FDA/CDER.
- Made significant contributions to the evaluation of nitrosamine surrogates led by the FDA/CDER starting in 2022 onward.
- Contributed to all nitrosamine-related memoranda for the FDA's nitrosamine RAIL guidance webpage.
- Preformed read-across assessments of extractable and leachable substances to assess potential general toxicity.
- Ensured accurate toxicity evaluations of extractable and leachable materials by reviewing surrogates proposed by the industry and recommending alternative surrogates when needed.
- Facilitated and provided training to internal groups, including OND, OGD, and OPQ.
- Represented the team through public-facing activities, such as talks and workshops, for diverse groups of external stakeholders, such as industry professionals and government employees.
- Analyzed data from toxicology studies to determine possible adverse effects of exposure to hazardous substances.
- Maintained and further developed FDA/CDER's structurally searchable database of tens of thousands of chemicals of regulatory interest.
- Assessed pharmaceutical firms' (Q)SAR assessments for alignment with regulatory standards under ICH M7 (R2).
- Facilitate and provide training to internal groups, including OND, OGD, and OPQ.
- Represented the team through public-facing activities, such as talks and workshops, for diverse groups of external stakeholders, such as industry professionals and government employees.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
Education
Bachelor of Science - Chemistry
Towson University
Towson, MD12.2021
Bachelor of Science - Molecular Biology/ Biochemistry/ Bioinformatics
Towson University
Towson, MD12.2021
Skills
- QSAR Methodology Application
- Computational Toxicology
- Database administration and development
- Information Oversight
- Workflow Optimization Strategies
- Microsoft office
- Pharmacokinetics and pharmacodynamics
- Chemoinformatics
- Documentation review
Awards
- CRC Press Chemistry Achievement Award Recipient, 2019
References
References available upon request.
Timeline
Computational Toxicologist
FDA Contractor
01.2022 - Current
Bachelor of Science - Chemistry
Towson University
Bachelor of Science - Molecular Biology/ Biochemistry/ Bioinformatics
Towson University
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