Meredith A. Calloway

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Analytical chemist with 9 years of experience in pharmaceutical QC and method development, specializing in HPLC, LC-MS/MS, and dissolution testing for small-molecule drug products. Reduced out-of-specification investigation cycle times by 34% at Vantara Pharma through root-cause protocol redesign. Holds USP Chapter 621 method validation expertise and an active DABT certification candidacy.

Work Experience

Senior Analytical ChemistMar 2020 - Present

Vantara Pharmaceuticals, Durham, NC

Developed and validated 11 HPLC and LC-MS/MS methods per ICH Q2(R1) guidelines, cutting average method-transfer time from 18 weeks to 11 weeks across three product lines.
Led root-cause investigation program for OOS results, redesigning the triage protocol and reducing average investigation cycle time by 34%, saving an estimated $420K annually in batch-hold costs.
Mentored 4 junior chemists on GMP documentation and instrument qualification, contributing to a zero-483-observation audit outcome in the 2023 FDA facility inspection.

Analytical Chemist IIJun 2017 - Feb 2020

Meridian BioSciences Contract Labs, Morrisville, NC

Executed dissolution, content uniformity, and stability testing for 6 generic drug ANDA submissions, supporting FDA approval timelines with 100% on-time data package delivery.
Optimized sample-prep workflow for a high-throughput plasma assay, increasing daily throughput from 48 to 120 samples and reducing solvent consumption by 22%.
Authored 14 SOPs and method transfer reports that became divisional templates, reducing new-analyst onboarding documentation time by 40%.

Chemist IAug 2015 - May 2017

Halcyon Specialty Chemicals, Raleigh, NC

Performed raw-material and in-process QC testing using FTIR, GC-FID, and titration methods for a portfolio of 30+ industrial chemical products.
Identified a systematic calibration drift in two GC-FID units, coordinating corrective maintenance that eliminated a recurring 2.1% systematic error in purity reports.
Supported ISO 9001 re-certification by compiling instrument qualification records and gap analyses, contributing to zero major nonconformities at the surveillance audit.

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