Isaac Hoffman
Tamarac,FL
Summary
Detail-oriented Analytical Chemist with over 3 years in cGMP pharmaceutical labs, specializing in HPLC analysis and potency testing. Expertise in validated testing methods, LIMS, 21 CFR Part 11, and FDA regulations. Generates accurate, audit-ready data and supports OOS investigations in fast-paced QC environments.
Overview
3
3
years of professional experience
Work History
Serologist I
QuidelOrtho
Pompano Beach, Florida
02.2026 - Current
- Performed aseptic techniques in cleanroom environments, ensuring strict contamination control adherence.
- Executed manufacturing processes in compliance with cGMP, SOPs, and safety regulations, successfully meeting production schedules in a fast-paced environment.
- Formulated large-scale batches per master batch records and recipe-driven processes, ensuring quality through raw material handling and in-process testing.
- Maintained accurate batch records and performed SAP/ERP transactions to ensure inventory accuracy.
- Inspected components for quality, managed scrap disposal per regulations, and maintained an organized workspace.
- Collaborated with team members to adapt to changing priorities, maintaining compliance and operational effectiveness.
Data Processing Chemist
ARL BioPharma
Remote, OK
11.2025 - 02.2026
- Processed and reviewed chromatography data using ChemStation software, ensuring adherence to QMS and cGMP standards to maintain data integrity.
- Verified accuracy of analytical results and identified discrepancies for correction within established guidelines.
- Maintained and managed analytical data in LIMS/LIMS 2, ensuring compliance with data integrity and documentation standards.
- Supported OOS investigations by reviewing data for discrepancies.
- Ensured documentation is complete, accurate, and audit-ready.
Associate Scientist
Transpire Bio
Weston, FL
09.2024 - 10.2025
- Conducted HPLC-based assays, impurity, and stability testing using Waters Empower 3 in compliance with cGMP standards.
- Executed inhalation product testing (APSD, DSD, DDU, SPPG) to ensure adherence to established protocols.
- Authored and assisted in writing and revising SOPs, STPs, Method Validations, and Method Developments.
- Mentored junior scientists in laboratory techniques and best practices.
- Developed and presented PowerPoint presentations to analytical team to convey data insights and findings.
Analytical Chemist
ARL BioPharma
Oklahoma City, Oklahoma
11.2022 - 07.2024
- Developed and validated analytical methods for pharmaceutical products.
- Conducted chemical analyses using chromatography and spectroscopy techniques.
- Utilized advanced laboratory instrumentation to conduct sample analyses, ensuring compliance with quality assurance standards.
- Collaborated with cross-functional teams to align analytical objectives with project goals.
- Maintained comprehensive records of all tests conducted, facilitating data integrity and traceability.
- Documented experiments and results in compliance with regulatory standards.
Education
Bachelor of Science - Biomedical Sciences
University of Southern Mississippi
Hattiesburg01-2021
Associate of Science - Biology
Mississippi Gulf Coast Community College
Perkinston01-2019
Skills
- Chromatography techniques
- Analytical instrumentation
- LIMS expertise
- FDA compliance
- cGMP compliance
- SOP documentation
- Data integrity
- Data management systems
- Attention to detail
- Effective communication
- Cross-functional collaboration
Timeline
Serologist I
QuidelOrtho
02.2026 - Current
Data Processing Chemist
ARL BioPharma
11.2025 - 02.2026
Associate Scientist
Transpire Bio
09.2024 - 10.2025
Analytical Chemist
ARL BioPharma
11.2022 - 07.2024
Bachelor of Science - Biomedical Sciences
University of Southern Mississippi
Associate of Science - Biology
Mississippi Gulf Coast Community College