R&D Chemist II — GMP, Method Development & Analysis

Nephron Pharmaceuticals Corporation; Columbia, Northern (SC, KY); Hybrid; USD 120,000 - 190,000; Full time

Job summary

Nephron Pharmaceuticals Corporation in the United States seeks a senior scientist to lead analytical method development for both established and new products. You will validate tests, transfer methods, and guide projects from concept to execution while ensuring GMP compliance.

Responsibilities include planning resources, generating GMP data, and collaborating with QA, manufacturing, and regulatory teams to support FDA submissions and product development timelines.

Qualifications

• Master’s degree in Chemistry or equivalent with cgMP exposure.
• 8–10 years of experience in a cGMP environment.
• Experience validating/ transferring analytical methods and troubleshooting.

Responsibilities

• Capable of working in a GMP environment and generating GMP data.
• Capable of applying analytical techniques (HPLC, UPLC, GC, FT-IR, UV/Vis) for R&D and QC.
• Execute R&D projects for product development, formulation, and process development.
• Evaluate new raw materials for quality and safety before use in GMP batches.
• Draft and review R&D and QC protocols and reports.
• Oversee reports, development summaries, and documentation for clients/health authorities.

Skills

LCMS

HPLC

UPLC

GC

FT-IR

UV/Vis spectroscopy

Interpersonal & writing

Education

Master’s Degree in Chemistry

Tools

Microsoft Word

Excel

PowerPoint

Project

Job description

Nephron Pharmaceuticals Corporation in the United States seeks a senior scientist to lead analytical method development for both established and new products. You will validate tests, transfer methods, and guide projects from concept to execution while ensuring GMP compliance.

Responsibilities include planning resources, generating GMP data, and collaborating with QA, manufacturing, and regulatory teams to support FDA submissions and product development timelines.