Executive, Inhalation CMC

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Amneal Pharmaceuticals in India seeks an analytical scientist to support inhalation CMC activities, developing and validating analytical methods for inhalation drug products and ensuring data integrity for regulatory submissions.

You will plan experiments on trial batches, evaluate exposure and stability studies, and coordinate day-to-day activities across multiple projects to meet timelines. This role builds scientific knowledge and supports transfers to commercial sites.

Qualifications

• B. Pharm required.
• Master's degree (MS/MA) in a related field preferred.
• 5+ years of experience in inhalation CMC beneficial.

Responsibilities

• Support analytical method development and validation for inhalation drug products.
• Perform tests for MDI DPI dosage forms (APSD, DDU, SP-PG).
• Conduct aerodynamic particle size distribution and delivered dose uniformity tests.
• Plan and execute inhalation trial batch experiments; evaluate exposure and stability.
• Set product specifications for inhalation products and validate methods.
• Maintain lab equipment and ensure data integrity.
• Support stability studies and coordinate project activities for regulatory submissions.
• Assist in analytical method transfers to commercial sites and troubleshoot.
• Contribute to exploratory research and new inhalation CMC methodologies.

Education

B. Pharm

M. Sc.

Job description

JOB 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

Education

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

Experience

• 5 years or more in 5 - 8 Years

About Us

Amneal is an equal opportunity employer. We do not discriminate based based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

• Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
• Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
• Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
• Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
• Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.