Senior Executive, Analytical R&D Injectable

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals in India seeks a seasoned analytical scientist to support DS and DP development by applying analytical methods to evaluate critical quality attributes and align products with reference formulations.

You will plan controlled experiments, evaluate trial batches, run exposure and stability studies, and ensure data integrity for regulatory submissions, method transfer, and troubleshooting.

Qualifications

• Master's degree in a relevant field is required.
• M. Pharm is preferred.
• Minimum 5 years of experience in pharmaceutical analytics.

Responsibilities

• Develop and apply analytical methods for DS and DP evaluation
• Perform identification, assay, impurity, and dissolution testing
• Evaluate formulation trials against reference product profiles
• Plan and execute controlled experiments on trial batches
• Conduct exposure and stability studies and document observations
• Support setting and justification of product specifications
• Perform analytical method validation as per intended use
• Ensure laboratory equipment operation, maintenance, and compliance
• Maintain data integrity for regulatory submission datasets
• Support analytical method transfer to commercial sites
• Troubleshoot analytical issues for R&D and commercial support
• Contribute to computational and experimental chemistry research

Skills

Analytical method development

DS/DP development

Experimental planning

Data integrity

Regulatory submissions support

Method transfer

Troubleshooting

Computational/experimental research

Education

Master Degree (MS/MA) M. Sc.

M. Pharm

Job description

JOB DESCRIPTION

The position supports drug substance (DS) and drug product (DP) development through development, validation, and application of analytical methods to evaluate critical quality attributes. The role contributes to product development across dosage forms by performing quantitative, qualitative, and performance-indicative testing to align products with reference formulations. The role involves planning controlled experiments, evaluating trial batches, exposure, and stability studies, and setting product specifications. The position ensures laboratory setup, equipment compliance, and data integrity for regulatory submissions and also supports analytical method transfer, commercial troubleshooting, and exploratory computational and experimental research, leveraging scientific data to guide research decisions and innovation.

Description

The position supports drug substance (DS) and drug product (DP) development through development, validation, and application of analytical methods to evaluate critical quality attributes. The role contributes to product development across dosage forms by performing quantitative, qualitative, and performance-indicative testing to align products with reference formulations. The role involves planning controlled experiments, evaluating trial batches, exposure, and stability studies, and setting product specifications. The position ensures laboratory setup, equipment compliance, and data integrity for regulatory submissions and also supports analytical method transfer, commercial troubleshooting, and exploratory computational and experimental research, leveraging scientific data to guide research decisions and innovation.

Essential Functions

• Develop and apply analytical methods for DS and DP evaluation
• Perform identification, assay, impurity, and dissolution testing
• Evaluate formulation trials against reference product profiles
• Plan and execute controlled experiments on trial batches
• Conduct exposure and stability studies and document observations
• Support setting and justification of product specifications
• Perform analytical method validation as per intended use
• Ensure laboratory equipment operation, maintenance, and compliance
• Maintain data integrity for regulatory submission datasets
• Support analytical method transfer to commercial sites
• Troubleshoot analytical issues for R&D and commercial support
• Contribute to computational and experimental chemistry research

Additional Responsibilities

• Raise indents, prepare Capex, and manage laboratory inventory.
• Taking responsibility to give training to junior for on job training
• Attend technical workshop /seminar and explore new technique and technology at work place

QUALIFICATIONS

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

Experience

• 5 years or more in 5 - 8 Years

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.

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.