Executive, Inhalation CMC
About the role
Description:
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 dosage forms, with a specific focus on inhalation chemistry, manufacturing, and controls activities. 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 inhalation CMC research programs within a global pharmaceutical organization.
Essential Functions:
Support inhalation CMC activities including analytical method development and validation for inhalation drug products
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 specific to inhalation dosage forms including aerodynamic particle size distribution and delivered dose uniformity
Plan and execute controlled research experiments on inhalation trial batches and evaluate exposure and stability studies
Set product specifications for inhalation products 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 related to inhalation products
Assist in analytical method transfers to commercial manufacturing sites and support troubleshooting activities for inhalation products
Conduct exploratory research to build scientific knowledge and contribute to new inhalation CMC methodologies
Document and maintain technical research information in compliance with regulatory and data integrity requirements
Additional Responsibilities:
Education:
B. Pharm B. Pharm - Required
Master Degree (MS/MA) M. Sc. - Preferred
Experience:
5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:
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