Pharma Analytical Chemist – Method Dev & Validation

Nivagen Pharmaceuticals Inc; Sacramento (CA); On-site; USD 75,000 - 76,000; Full time

Job summary

Pharmaceutical Manufacturing & Research Co. in Sacramento, CA is seeking a Research Chemist to develop and validate analytical methods for drug substances and products. You will perform stability and release testing using GC, GC-MS, LC-MS, HPLC or ICP-MS, ensuring data integrity and compliance with cGMP/GLP and FDA guidelines.

The role requires preparing technical reports, maintaining meticulous lab records, and supporting OOS investigations, CAPA activities, and ANDA/NDA submissions as needed.

Qualifications

• Perform method development, validation, and testing of drug substances and products.
• Conduct OOS investigations and CAPA in alignment with cGMP/GLP and FDA guidelines.
• Prepare technical reports and maintain accurate lab records.
• Support ANDA/NDA submissions as required.

Responsibilities

• Perform GC/GC-MS/LC-MS/HPLC/ICP-MS analyses.
• Prepare technical reports and maintain lab records.
• Assist in regulatory submissions under FDA guidelines.

Skills

Method development

Validation

Stability testing

Release testing

OOS investigations

CAPA

FDA guidelines

cGMP

GLP

Tools

GC

GC-MS

LC-MS

HPLC

ICP-MS

Job description

Pharmaceutical Manufacturing & Research Co. in Sacramento, CA is seeking a Research Chemist to develop and validate analytical methods for drug substances and products. You will perform stability and release testing using GC, GC-MS, LC-MS, HPLC or ICP-MS, ensuring data integrity and compliance with cGMP/GLP and FDA guidelines.

The role requires preparing technical reports, maintaining meticulous lab records, and supporting OOS investigations, CAPA activities, and ANDA/NDA submissions as needed.