Chemist II – Analytical Chemistry (HPLC/GC, cGMP)

Founded over 20 years ago and based in South Plainfield, NJ, we are an FDA-registered, cGMP-compliant analytical testing laboratory specializing in OTC drugs, pharmaceuticals, cosmetics, dietary supplements, and botanical products. We provide method development, validation, stability testing, and release testing services to support regulatory compliance and product quality. Our laboratory operates under strict FDA, DEA, ISO, and USP standards to ensure accurate, reliable analytical results for our clients.

About the role

This is a 100% onsite role in a fully equipped laboratory setting. You will work closely with Laboratory and QA associates in an FDA-regulated environment, gaining exposure to method development, validation, and QA collaboration.

Responsibilities

• Independently execute validated analytical methods using LC, GC, IR, UV, dissolution, viscosity, melting point, and related instrumentation
• Prepare samples of OTC drug, pharmaceutical, cosmetic, dietary supplement, and botanical products
• Process and review instrument data (LC, GC, ICP-MS, etc.) for QA-ready reporting
• Maintain detailed, compliant documentation in accordance with FDA cGMP requirements
• Support method development, verification, validation, and transfer activities
• Participate in investigations including deviations, OOS/OOT, and CAPA
• Maintain laboratory equipment including calibration and troubleshooting
• Adhere to OSHA, chemical safety, and waste disposal procedures
• Occasionally assist with microbiology-related activities (media prep, environmental monitoring, aseptic handling)

Requirements

• Bachelor’s degree in Chemistry (required)
• Minimum 3–5 years of experience in an industry chemistry lab (FDA-regulated preferred)
• Strong hands-on experience with HPLC and GC methods
• Experience working in FDA cGMP environments
• Familiarity with USP, ICH, and related regulatory guidelines
• Experience participating in OOS/OOT investigations and CAPA
• Ability to work independently in a fast-paced lab setting
• Basic microbiology exposure (media prep, aseptic techniques, environmental monitoring)
• Must be legally authorized to work in the US
• Must be able to commute to South Plainfield, NJ (no relocation)

Benefits

• Competitive compensation: market-aligned base salary (DOE)
• Stability and growth within an established FDA-regulated analytical lab
• Extensive hands-on exposure to instrumentation (LC, GC, ICP-MS, UV, IR, dissolution, etc.)
• Professional development through method development, validation, and QA collaboration
• Team-oriented work environment

Pay

$70,000 - $80,000 per year