Method Validation Scientist – GMP Pharma Analytics

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

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks Method Validation Research Chemists to join our GMP lab environment. You will set up and operate analytical instruments, perform release testing on raw materials, in-process, and stability samples, and help prepare validation protocols.

Candidates should have a chemistry degree with GMP method validation experience; mentoring of junior staff and strict adherence to cGMP and safety policies are required.

Qualifications

• Bachelor's in Chemistry or related science field with 5 years GMP method validation lab experience.
• Alternatively, Master's in Chemistry or related field with 3 years GMP method validation exp.
• Proficiency with spectroscopic and chromatographic techniques and analysis in pharma manufacturing.

Responsibilities

• Set up and operate instruments (HPLC, GC, IR, UV/Vis, ICP-MS) and report results.
• Perform raw material, in-process, drug product and stability testing per USP/EP in GMP labs.
• Develop/validate/transfer methods; prepare protocols and reports.
• Train junior chemists and participate in investigations and root cause analyses.
• Maintain instrument calibration, data processing, and document laboratory records per cGMP.
• Ensure safety rules and company policies; meet deadlines.

Skills

Spectroscopy

Chromatography

Analytical instrumentation

Regulatory compliance (cGMP/FDA/OSHA)

Education

Bachelor's in Chemistry or related science

Master's in Chemistry or related science

Tools

Empower

Microsoft Office

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks Method Validation Research Chemists to join our GMP lab environment. You will set up and operate analytical instruments, perform release testing on raw materials, in-process, and stability samples, and help prepare validation protocols.

Candidates should have a chemistry degree with GMP method validation experience; mentoring of junior staff and strict adherence to cGMP and safety policies are required.