Senior Analyst - Injectable Analytics & Method Development

Lupin Ltd; Indiana; On-site; USD 90,000 - 140,000; Full time

Job summary

Lupin Ltd is seeking an experienced analytical scientist in Indiana to lead development and validation of analytical methods for dissolution/in-vitro release of complex injectables. The role covers method development, validation, and transfer to QC within a GLP/GMP framework.

You will perform routine and stability analyses, support FDA interactions, and ensure compliance with quality standards while collaborating with R&D and manufacturing teams.

Qualifications

• 7 to 9 years of experience in analytical development for injectables.
• Advanced degrees (MS or PhD) in Pharmaceutical/Analytical Chemistry.
• Experience with GLP/GMP and QA compliance for injectable products.

Responsibilities

• Routine and stability sample analysis of complex injectables and other injectable products.
• Extensive literature search for fast method development.
• Excipient evaluation for complex injectables and other injectable products.
• Method equivalency assessment and analytical method transfer to QC under quality standards.
• Address FDA queries within stipulated timelines.
• Interpreting analytical data from R&D and plant stability studies for stakeholders.
• Operating and calibrating analytical instruments as required.
• Managing day-to-day analytical laboratory activities per GLP/GMP guidelines.
• Maintaining the work area in compliance with GLP, GMP, and safety guidelines.

Skills

Analytical method development

Validation

GLP/GMP compliance

Education

Masters in Pharmaceutical Chemistry or Analytical Chemistry

Doctorate in Pharmaceutical Chemistry or Analytical Chemistry

Job description

Lupin Ltd is seeking an experienced analytical scientist in Indiana to lead development and validation of analytical methods for dissolution/in-vitro release of complex injectables. The role covers method development, validation, and transfer to QC within a GLP/GMP framework.

You will perform routine and stability analyses, support FDA interactions, and ensure compliance with quality standards while collaborating with R&D and manufacturing teams.