Senior Executive / Assistant Manager, Inhalation CMC

Description:

This role is responsible for supporting the development of drug substance and drug product by designing and executing suitable analytical methods to evaluate quality attributes across various dosage forms. The position contributes to product development by performing quantitative, qualitative, and performance-indicative tests to align product profiles with reference formulations. It involves planning and executing controlled research experiments on trial batches, evaluating exposure and stability studies, and recording scientific observations with precision. The role supports the setting of product specifications and performs analytical method validation to confirm that methods meet their intended purpose within defined specification ranges. It ensures the operation and compliance of the laboratory environment, including setup, configuration, installation, and maintenance of equipment, while maintaining data integrity for regulatory submissions. The position supports stability studies and coordinates multiple projects on a day-to-day basis to meet regulatory timelines. It also facilitates analytical method transfer to commercial sites and addresses troubleshooting activities related to commercial support. Additionally, the role contributes to computational and experimental chemistry-based research, conducting exploratory studies to build scientific knowledge and deliver new methodologies. It leverages experimental data to drive key decisions and shape the direction of the research program within a global pharmaceutical context.

Essential Functions:

• Develop and execute analytical methods for drug substance and drug product to evaluate quality attributes across multiple dosage forms
• To perform test of MDI DPI dosage forms like APSD, DDU, SP-PG, Particulate matter for drug products
• Perform quantitative, qualitative, and performance-indicative tests including identification, assay, related impurities, and dissolution to match product profiles with reference formulations
• Plan and set up controlled research experiments on trial batches and evaluate exposure and stability studies with accurate recording of observations
• Establish product specifications in alignment with regulatory and pharmacopoeial requirements
• Conduct analytical method validation to confirm the intended purpose of methods within defined specification ranges
• Maintain laboratory compliance including setup, configuration, installation, and maintenance of equipment while ensuring data integrity of scientific datasets for regulatory submissions
• Support stability studies for regulatory submissions and coordinate day-to-day prioritization of multiple concurrent projects
• Facilitate analytical method transfer to commercial manufacturing sites and resolve troubleshooting issues related to commercial support
• Contribute to computational and experimental chemistry-based research to build scientific knowledge and develop new methodologies and products

Additional Responsibilities:

• B. Pharm B. Pharm - Required

• Master Degree (MS/MA) M. Sc. - Preferred

• 5 years or more in 5 - 8 Years