Pharma Research Chemist — GMP/QA Analytical Expert

nivagenpharmaceuticals; Sacramento (CA); On-site; USD 75,000 - 105,000; Full time

Job summary

Nivagen is seeking a chemist to perform analytical testing on raw materials, in-process materials, and finished dosage forms. You will ensure data quality and regulatory compliance under GMP, GLP, GDP, and ICH/FDA guidelines.

The role involves method development and stability studies, supporting product development and regulatory submissions, with emphasis on accurate data generation and collaboration with QA and R&D teams.

Qualifications

• Bachelor's or Master's in Chemistry/Pharma or related field.
• 1–5 years of experience in a pharmaceutical quality control lab.
• Experience with GMP, GLP, and GDP requirements.
• Familiarity with regulatory guidelines (ICH/FDA) is preferred.

Responsibilities

• Operate and maintain analytical instruments (GC, GC-MS, LC-MS, HPLC) with UV-Vis, PDA, and CAD detectors.
• Ensure calibration and routine maintenance of lab equipment for accuracy and precision.
• Develop and validate analytical methods per ICH and FDA guidelines.
• Perform quantitative/qualitative analyses on materials using validated methods.
• Conduct stability studies following ICH guidelines and document results for submissions.

Skills

HPLC

GC/GC-MS

ICH/FDA guidelines

GLP/GMP/GDP compliance

Analytical method development

Education

Bachelor's or Master's in Chemistry/Pharma

Tools

GC/LC-MS instruments

FTIR/UV-Vis equipment

Job description

Nivagen is seeking a chemist to perform analytical testing on raw materials, in-process materials, and finished dosage forms. You will ensure data quality and regulatory compliance under GMP, GLP, GDP, and ICH/FDA guidelines.

The role involves method development and stability studies, supporting product development and regulatory submissions, with emphasis on accurate data generation and collaboration with QA and R&D teams.