Research Associate : Pharma Research Injectable

Lupin; Pune District; On-site; INR 1,400,000 - 1,900,000; Full time

Job summary

Lupin in Pune is seeking a Research Associate for Pharma Research Injectables. The role involves analytical method development, validation, and transfer for complex injectables including suspensions, emulsions, microspheres, and LAI.

You will support regulatory activities and address FDA queries with timely, data-driven insights. The ideal candidate holds a Masters or PhD in Pharmaceutical/Analytical Chemistry and has 7–9 years of hands-on experience in analytical method development, GLP/GMP

Qualifications

• Develop and validate analytical methods for dissolution and in-vitro release of complex injectables.
• Perform method transfer to QC and address regulatory queries (FDA).
• Assess excipients for complex injectables and confirm method equivalency.

Responsibilities

• Perform routine and stability analysis of complex injectables.
• Conduct extensive literature searches for rapid method development.
• Evaluate excipients for injectable products and ensure compliance with PIL.
• Transfer methods to QC and address regulatory queries within timelines.
• Interpret analytical data from R&D and plant stability studies for stakeholders.
• Operate and calibrate analytical instruments; maintain GLP/GMP compliance.
• Maintain GLP, GMP and safety in the laboratory environment.

Skills

Analytical method development

Literature review

GLP/GMP awareness

Education

M.Pharm in Pharmaceutical Chemistry or Analytical Chemistry

PhD in Pharmaceutical Chemistry or Analytical Chemistry

Tools

USP Type I/II/IV

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

Connect With Us

Follow our social channels to get a
glimpse of life at Lupin