Isaac Hoffman
Tamarac,FL
Summary
Detail-oriented and analytical scientist with a BS degree in Biological Sciences and a minor in Chemistry. Extensive experience in pharmaceutical testing, including APSD, DSD, DDU, SPPG, Assay, Related Substances, BKC, and FTIR. Skilled in method development and validation, report writing, SOP and STP creation, and GMP compliance. Proficient in HPLC instrumentation and data processing using ChemStation software. Committed to delivering accurate, reliable results and supporting regulatory submissions with high-quality documentation.
Overview
4
4
years of professional experience
Work History
Associate Scientist
Transpire Bio
09.2024 - Current
- Perform device characterization and chemical testing of inhalation and nasal drug products under GMP guidelines, including APSD (Aerodynamic Particle Size Distribution), DSD (Droplet Size Distribution), DDU (Delivered Dose Uniformity), SPPG (Spray Pattern and Plume Geometry), Assay, Related Substances, BKC, and FTIR analysis.
- Conduct method development and validation activities, including ensuring compliance with ICH and FDA regulatory requirements.
- Author technical reports, validation protocols, SOPs (Standard Operating Procedures), and STPs (Standard Test Procedures) to support analytical development and regulatory submissions.
- Collaborate with cross-functional teams to troubleshoot analytical challenges, optimize methods, and ensure accuracy and reliability of test results.
- Train team-members on chemical and device performance testing.
- Maintain strict adherence to cGMP standards, proper documentation practices, and quality system procedures in all laboratory activities.
Analytical Chemist
ARL Biopharma
11.2022 - 07.2024
- Performed analysis of pharmaceutical finished products using various methods to test for purity.
- Utilized established AMIF methods, software, and instrumentation (HPLC, ChemStation) to analyze pharmaceutical substances and formulations.
- Accurately recorded results in LIMS2 in compliance with cGMP and QMS.
- Mentored junior team members on protocols, sample preparation, and troubleshooting.
- Performed OOS (Out-of-Specification) investigations per QMS guidelines.
Lab Technician
ARL Biopharma
08.2022 - 11.2022
- Maintained laboratory cleanliness; calibrated balances and pH meters daily.
- Tracked solvents, reagents, supplies, and standards; removed expired materials from LIMS.
- Prepared mobile phases, reagents, and solutions daily.
- Performed peer reviews of laboratory notebooks.
- Ensured timely testing of samples to meet deadlines.
Laboratory Support Technician
Mercy Hospital Oklahoma City
02.2022 - 07.2022
- Collected and processed specimens for laboratory testing while adhering to HIPAA compliance.
- Performed PCR testing using BioFire and managed incubation of specimens.
- Conducted microbial identification using Vitek and assisted pathologists with tissue analysis.
- Conducted hematology analyzer QC checks, calibration, and troubleshooting.
Education
Bachelor of Science - Biomedical Sciences, Minor in Chemistry
The University of Southern Mississippi
Hattiesburg, MS01.2021
Associate of Science - Biology
Mississippi Gulf Coast Community College
Perkinston, MS01.2019
Timeline
Associate Scientist
Transpire Bio
09.2024 - Current
Analytical Chemist
ARL Biopharma
11.2022 - 07.2024
Lab Technician
ARL Biopharma
08.2022 - 11.2022
Laboratory Support Technician
Mercy Hospital Oklahoma City
02.2022 - 07.2022
Associate of Science - Biology
Mississippi Gulf Coast Community College
Bachelor of Science - Biomedical Sciences, Minor in Chemistry
The University of Southern Mississippi
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