Method Validation Chemist - GMP Pharmaceutical Analytics Lead

Tris Pharma, Inc.; South Brunswick (NJ); On-site; USD 114,000 - 128,000; Full time

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking a Method Validation Research Chemist to set up and operate analytical instruments, validate methods, and support release and stability testing in a GMP laboratory.

The role requires hands-on use of HPLC, GC, UV/Vis, IR, KF, ICP-MS and other instruments. Responsibilities include preparing validation protocols, performing test analyses, reviewing results, and contributing to investigations while training junior staff.

Qualifications

• Bachelor's or Master's degree in chemistry or related field with GMP pharma experience.
• Experience with analytical method validation and transfer under GMP.
• Knowledge of spectroscopic and chromatographic techniques and instruments.

Responsibilities

• Set up and operate analytical instruments for sample testing (HPLC, GC, IR, UV/Vis, KF, ICP-MS).
• Prepare validation/verification/transfer protocols and reports.
• Perform method validation and verification activities for drug substances and dosage forms.
• Analyze results, document in lab notebooks, and ensure cGDP/cGMP compliance.
• Train and mentor junior chemists and participate in investigations.

Skills

Spectroscopic/Chromatographic skills

Analytical instrumentation

Regulatory compliance (cGMP, FDA, OSHA

Data analysis and calculations

Education

Bachelor's degree in Chemistry or related science

Master's degree in Chemistry or related science

Tools

HPLC

UPLC

GC

ICP-MS

UV-VIS

IR

Karl Fischer

Particle size analyzer

Dissolution instruments

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking a Method Validation Research Chemist to set up and operate analytical instruments, validate methods, and support release and stability testing in a GMP laboratory.

The role requires hands-on use of HPLC, GC, UV/Vis, IR, KF, ICP-MS and other instruments. Responsibilities include preparing validation protocols, performing test analyses, reviewing results, and contributing to investigations while training junior staff.