Executive, Analytical R&D Injectable (Development)

Description:

Analytical Development - Injectable & Complex Injectable

This role supports the development of drug substances and drug products by contributing to the design and execution of analytical methods used to evaluate quality attributes across various Injectable dosage forms. The position assists in evaluating proposed formulation trials through quantitative, qualitative, and performance-indicative testing to align product profiles with reference formulations. It plans and executes controlled research experiments on trial batches, including exposure and stability studies, while maintaining accurate scientific records. The role supports the setting of product specifications and performs analytical method validation to confirm the suitability of methods against defined specification ranges. It ensures the operation and compliance of laboratory environments, including equipment setup, configuration, installation, and maintenance, while upholding data integrity standards for regulatory submissions. The position supports stability studies and coordinates day-to-day activities across multiple projects to meet regulatory submission timelines. It contributes to analytical method transfers to commercial sites and assists in troubleshooting activities related to commercial support. The role also participates in computational and experimental chemistry-based research during various stages of the R&D cycle, building scientific knowledge and delivering new methodologies. It leverages experimental data to inform key decisions and shape the direction of research programs within a global pharmaceutical organization.

Essential Functions:

• Support development of analytical methods for drug substances and drug products across various dosage forms
• Perform quantitative, qualitative, and performance-indicative tests including identification, assay, related impurities, and dissolution studies
• Plan and execute controlled research experiments on trial batches and evaluate exposure and stability studies
• Set product specifications and perform analytical method validation against defined specification ranges
• Maintain laboratory equipment through setup, configuration, installation, and routine maintenance while ensuring data integrity
• Support stability studies and coordinate day-to-day project activities for regulatory submissions
• Assist in analytical method transfers to commercial manufacturing sites and support troubleshooting activities
• Conduct exploratory research to build scientific knowledge and contribute to new methodologies and product development
• Document and maintain technical research information in compliance with regulatory and data integrity requirements

Additional Responsibilities:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

• 5 years or more in 5 - 8 Years