Yasmin Haddad
Analytical Chemist | HPLC/LC-MS Method Development under cGMP | 12 methods validated to ICH Q2
- Durham, NC
- yasmin.haddad@example.com
- +1 (919) 555-0116
- linkedin.com/in/your-name
Summary
Analytical chemist with nine years in Research Triangle pharmaceutical labs, developing and validating HPLC, UPLC and GC methods for oral solid products. Leads OOS investigations, writes validation and transfer protocols, and identifies unknown impurities by LC-MS. Recent work shortened a related substances method by two thirds and passed a pre-approval inspection with no method findings.
Work Experience
Senior Analytical Chemist
Apr 2021 – Present
Neuse Point Pharma Services · Durham, NC
- Developed a UPLC related substances method that runs in 18 minutes instead of 55, with better resolution of the critical pair.
- Validated 12 methods for a new tablet product; the pre-approval inspection raised no method findings.
- Identified a 0.12% degradant by LC-MS and forced degradation data, supporting a switch to foil blister packaging.
Analytical Chemist
Feb 2018 – Mar 2021
Crabtree Valley Laboratories · Morrisville, NC
- Led 18 OOS investigations in a year, closing each inside 30 days and tracing most to sample preparation steps.
- Transferred 9 methods to contract labs, with every transfer passing comparative testing on the first try.
- Set a preventive maintenance schedule for 8 HPLC systems that cut downtime 40%.
QC Chemist (Contract)
Jan 2017 – Jan 2018
Haw River Generics · Sanford, NC
- Ran assay, dissolution and Karl Fischer testing on 600 release samples under cGMP.
- Recorded and reviewed data to ALCOA+ standards with zero documentation errors flagged at internal audit.
Education
Bachelor of Science, Chemistry (ACS-certified)
2012 – 2016
University of North Carolina at Greensboro
Skills
Core competencies
- HPLC/UPLC Method Development
- ICH Q2 Method Validation
- LC-MS Impurity Identification
Instruments & Software
- Waters UPLC & Empower 3
- Agilent GC-FID & Headspace
- Thermo LC-MS
- Karl Fischer & Dissolution
Quality Systems
- cGMP (21 CFR 211)
- OOS Investigations & CAPA
- Part 11 Audit Trail Review
- LIMS
Certifications
- Certified Pharmaceutical GMP Professional (CPGP) · American Society for Quality (ASQ), 2022
Languages
- English · Native
- Arabic · Professional working proficiency