Research Associate : Pharma Research Injectable

Lupin; Nashik District; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Lupin is seeking a Research Associate : Pharma Research Injectable in Pune. The role focuses on analytical method development and validation for dissolution/in-vitro release, including complex injectables such as suspensions, emulsions, microspheres, and LAIs.

Responsibilities include routine and stability analysis, literature search for rapid method development, excipient evaluation, and method transfer to QC in line with GLP/GMP standards; you will address FDA queries and communicate results

Qualifications

• Masters in Pharmaceutical Chemistry or Analytical Chemistry is required.
• Doctorate in Pharmaceutical Chemistry or Analytical Chemistry is preferred.
• 7 to 9 years of relevant experience in injectables analytics.
• Strong knowledge of GLP/GMP guidelines.

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 in compliance with quality and ethical standards for injectable products.
• Addressing FDA queries within the stipulated timelines.
• Interpreting analytical data from R&D and plant stability studies and communicating findings to relevant stakeholders.
• Operating and calibrating analytical instruments as required.
• Managing day-to-day analytical laboratory activities in accordance with GLP/GMP guidelines.
• Maintaining the work area in compliance with GLP, GMP, and safety guidelines

Skills

Analytical method development

GLP/GMP compliance

Instrument calibration

FDA query handling

Literature search

Method transfer to QC

Education

Master's in Pharmaceutical Chemistry or Analytical Chemistry

PhD in Pharmaceutical Chemistry or Analytical Chemistry

Tools

Mastersizer

Zetasizer

Rheometer

Brookfield Viscometer

Job description

Research Associate : Pharma Research Injectable

• Date: Oct 13, 2026
• Location: Pune_RD, MH, IN
• Company: Lupin

• Analytical method development and validation for dissolution/in-vitro release using USP Type I, II, IV, shaking water bath, bottle rotating apparatus, or other suitable techniques. Particle size distribution and Zeta potential (Mastersizer/Zetasizer), Viscosity (Rheometer/Brookfield), Assay and degradation product/content testing, including preservative and antioxidant analysis for complex injectables (Including Suspensions, Emulsion, Microsphere and LAI).
• Reverse engineering of complex injectables (Including Suspensions, Emulsion, Microsphere and LAI) and other injectable products.
• Analytical method development for admixture and dilution studies in line with the product information leaflet (PIL) for injectable products.

Responsible for:

• 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 in compliance with quality and ethical standards for injectable products.
• Addressing FDA queries within the stipulated timelines.
• Interpreting analytical data from R&D and plant stability studies and communicating findings to relevant stakeholders.
• Operating and calibrating analytical instruments as required.
• Managing day-to-day analytical laboratory activities in accordance with GLP/GMP guidelines.
• Maintaining the work area in compliance with GLP, GMP, and safety guidelines

Work Experience

7 to 9 years

Education

Masters in Pharmaceutical Chemistry or Analytical Chemistry

Doctorate in Pharmaceutical Chemistry or Analytical Chemistry

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