Senior Method Validation Chemist — GMP Pharma Analytics

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

Job summary

Tris Pharma, Inc. is seeking a Method Validation Research Chemist in our Monmouth Junction, NJ facility to lead analytical method validation and testing activities.

You will operate instrumentation (HPLC, GC, IR, UV/Vis, ICP-MS, dissolution) and prepare validation protocols in a GMP-regulated laboratory environment, ensuring compliance with USP/EP and company SOPs. Training and mentoring junior staff are expected.

Qualifications

• Bachelor's degree in chemistry or related science with 5 years in Method Validation Lab under GMP in pharma.
• Master's degree in chemistry or related science with 3 years in Method Validation Lab under GMP in pharma.
• Any suitable combination of education, training or experience accepted.
• Experience with spectroscopic and chromatographic techniques in pharmaceutical manufacturing.

Responsibilities

• Set up and operate analytical instruments (HPLC, GC, IR, UV/Vis, KF, ICP-MS, dissolution) for testing.
• Prepare validation/verification/transfer protocols and reports.
• Test raw materials, in-process and drug products per USP/EP monographs in GMP environments.
• Train/mentor junior chemists and support investigations and root-cause analyses.
• Maintain and calibrate lab instruments and ensure compliance with cGDPs/cGMPs.

Skills

Spectroscopy

Chromatography

Analytical instrumentation

cGMP/FDA/OSHA

Quality systems

Wet chemistry

Analytical investigations

Method validation transfer

Education

Bachelor's in Chemistry or related science

Master's in Chemistry or related science

Tools

Microsoft Office

Empower software

Job description

Tris Pharma, Inc. is seeking a Method Validation Research Chemist in our Monmouth Junction, NJ facility to lead analytical method validation and testing activities.

You will operate instrumentation (HPLC, GC, IR, UV/Vis, ICP-MS, dissolution) and prepare validation protocols in a GMP-regulated laboratory environment, ensuring compliance with USP/EP and company SOPs. Training and mentoring junior staff are expected.