Analytical Chemist with 20+ Years Experience (Wage Flex)

Roger Horng

Email: **************@*****.***

Phone: 973-***-**** (mobile)

Location: Essex County, NJ

Experience Summary

Highly skilled Analytical Chemist with extensive (20+ years) expertise in HPLC, UPLC, GC, ICP-MS,

LC/MS, UV/VIS, FTIR, TGA, DSC, and dissolution testing for pharmaceutical, dietary supplement,

and cosmetic applications. Proficient in LIMS (LabWare), CDS (Empower, Chromeleon), and 21 CFR

Part 11 compliance for data integrity. Deep knowledge of GMP/GLP (21 CFR 210/211, 21 CFR 111),

USP/NF, EP, and ICH guidelines for method validation and quality control.

Key accomplishments include developing stability-indicating methods, leading successful method

transfers (including international projects), and resolving complex chromatographic issues. Adept

at impurity identification (LC/MS), particle characterization (Malvern), and excipient compatibility

studies. Established new analytical laboratories, including instrument qualification and SOP

development.

Recognized for meticulous documentation, strong technical writing (SOPs, validation reports,

investigations), and cross-functional collaboration with Formulation, QA, and Regulatory teams.

Combines problem-solving skills with adaptability in fast-paced GMP environments to deliver

compliant, high-quality analytical solutions.

Professional Experience

Nicepak/PDI Inc.

Analytical Chemist III 01/2021 – 04/2025

Troubleshot analytical methods for the company

Performed analysis of products, raw materials, and stability samples using HPLC and GC

Managed test data using LIMS and LabWare systems

Consumer Product Testing Company, Inc.

Senior Chemist 05/2018 – 10/2020

Proposed method verification approaches, performed tests, and wrote verification reports

Analyzed raw materials, products, and stability samples using USP/EP methods as

requested by clients

PDA Analytical Laboratories, LLC

Principal Scientist 09/2016 – 05/2018

Developed and validated analytical methods (HPLC, GC, UV) for cosmetic, pharmaceutical,

and dietary supplement samples

Wrote validation reports (analytical and cleaning validation)

Troubleshot and improved HPLC and GC methods provided by clients

Nutrisport Pharmacal Inc.

Principal Scientist 02/2009 – 09/2016

Set up analytical instruments (HPLC, GC) for new laboratory

Developed and validated analytical chemistry methods using HPLC, GC, and ICP-MS

Performed analytical tests and stability operations

Supervised chemists for routine testing

Wrote SOPs and methods to comply with CFR Part 111 (Dietary Supplement Regulation)

Par Pharmaceutical Inc.

Senior Scientist (Group Leader) 01/2007 – 12/2008

Scientist III 04/2006 – 01/2007

Senior Chemist 06/2000 – 04/2006

Reviewed and corrected chemists' notebooks

Troubleshot analytical methods (Malvern 2000S, HPLC, UPLC, GC)

Performed API analysis (particle size, assay, impurity)

Investigated unknown impurities from QC stability samples using HPLC/MS

Traveled to Bangalore, India to prepare method transfer protocols and perform method

transfers (GC, HPLC, Malvern particle size distribution)

Conducted pH solubility studies and excipient compatibility for formulation development

Developed and validated analytical methods (HPLC, UPLC, UV, GC, FTIR)

Authored validation protocols and reports

Trained chemists in the United States and India on instruments and software

Performed wet and instrumental analysis of dosage forms (HPLC, UPLC, UV, GC, LC/MS,

FTIR, TGA, DSC, Malvern)

Wyeth-Ayerst Pharmaceuticals

Analytical Development Chemist 11/1998 – 06/2000

Developed analytical methods (GC, HPLC, UV/VIS, and Titrimetric) in support of

manufacturing and transferred these methods to quality control laboratories.

Calibrated HPLC and dissolution instruments.

Authored SOPs

EDUCATION & CERTIFICATIONS

Ph.D. in Engineering Science New Jersey Institute of Technology (NJIT)

M.S. in Chemical Engineering NJIT

B.S. in Chemical Engineering Chung Yuan University, Taiwan

TECHNICAL SKILLS

Instruments: HPLC, UPLC, GC, ICP-MS, LC/MS, UV/VIS, FTIR, DSC, TGA, Malvern Particle Size

Regulations: GMP/GLP, FDA 21 CFR, ICH Q2, USP/NF, EP

Software: LIMS, LabWare, Empower, Chromeleon

Languages: English, [Others if applicable]

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