Executive, Inhalation CMC

Amneal Pharmaceuticals LLC; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a qualified individual to advance analytical methods for inhalation drug products. You will develop and validate methods, perform APSD, DDU, and SP-PG tests, and evaluate stability on trial batches, ensuring data integrity for regulatory submissions.

The role requires a B.Pharm and 5–8 years of relevant experience, with preference for MS/MA or M.Sc. You will work across multiple projects to support regulatory timelines and method transfers to

Qualifications

• B.Pharm is required; MS/MA, M.Sc. preferred.
• 5–8 years of relevant experience.
• Specialized knowledge in material science, excipient selection, product characterization, and testing.

Responsibilities

• Support inhalation CMC activities including analytical method development and validation.
• Perform tests on MDI/DPI dosage forms and aerosol metrics.
• Plan and execute inhalation trial batches and evaluate stability studies.
• Set product specifications and validate analytical methods.
• Maintain lab equipment and ensure data integrity for regulatory submissions.
• Coordinate day-to-day project activities for regulatory deadlines.
• Assist in analytical method transfers to commercial sites and support troubleshooting.

Skills

Data integrity

Documentation

Regulatory compliance

Stability studies

Inhalation CMC

Material science

Product characterization

Testing

Education

Bachelor's degree in Pharmacy

Master's degree

Tools

APSD

DDU

SP-PG

Job description

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.
• Perform tests of MDI/DPI dosage forms such as APSD, DDU, SP‑PG, and 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.

Qualifications

• Education: B. Pharm (required). Master’s degree (MS/MA, M. Sc.) preferred.
• Experience: 5‑8 years in a relevant field.
• Specialized knowledge: Material science, excipient selection, product characterization, and testing.

Required Skills

• Data integrity and documentation security.
• Documentation and record control.
• Material science and excipient selection.
• Product characterization and testing.
• Quality assurance.
• Regulatory compliance.
• Regulatory process management.
• Regulatory reporting and documentation oversight.
• Regulatory requirements interpretation.
• Stability studies and shelf‑life determination.

About Us

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