Pharma Method Validation Scientist | GMP & Method Transfer

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

Benefits offered by this job

Comprehensive benefits

Job summary

Tris Pharma, Inc. is seeking a Method Validation Research Chemist to join the Monmouth Junction, NJ team. You will set up and operate analytical instruments (HPLC, GC, IR, UV/Vis, KF, ICP-MS) and perform release testing, validation, and method transfer in a regulated lab.

You will prepare protocols and reports, review data, and help train junior chemists while adhering to cGDPs, cGMPs, and SOPs. A strong background in GMP pharmaceutical method validation is required, with experience in a

Qualifications

• Bachelor's degree in Chemistry or related field with 5+ years GMP pharma method validation experience
• Master's degree in Chemistry or related field with 3+ years GMP pharma method validation experience
• Experience with validation/verification/transfer protocols and reports
• Proficiency with Empower software and analytical data handling
• Strong knowledge of analytical techniques in a regulated GMP lab

Responsibilities

• Set up and operate analytical instruments for sample testing in a GMP lab.
• Perform validation, verification, and transfer activities for analytical methods.
• Prepare validation/verification/transfer protocols and reports.
• Train and mentor junior chemists on instrument operation and data interpretation

Skills

Spectroscopy & Chromatography

cGMP & FDA regulations

Quality systems & data analysis

Analytical method validation & data

Microsoft Office & Empower

Education

Bachelor's degree in Chemistry or related field

Master's degree in Chemistry or related field

Tools

HPLC

GC

ICP-MS

UPLC

UV-Vis

IR

KF

Dissolution

pH meters

Job description

Tris Pharma, Inc. is seeking a Method Validation Research Chemist to join the Monmouth Junction, NJ team. You will set up and operate analytical instruments (HPLC, GC, IR, UV/Vis, KF, ICP-MS) and perform release testing, validation, and method transfer in a regulated lab.

You will prepare protocols and reports, review data, and help train junior chemists while adhering to cGDPs, cGMPs, and SOPs. A strong background in GMP pharmaceutical method validation is required, with experience in a