Research Associate : Pharma Research Injectable

Lupin Ltd; Indiana; Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Analytical method development

Validation

GLP/GMP compliance

Educación

Masters in Pharmaceutical Chemistry or Analytical Chemistry

Doctorate in Pharmaceutical Chemistry or Analytical Chemistry

Descripción del empleo

• 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.

Job Description

Expertise in:

• 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

Competencies

Expertise In:

• 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

Competencies