Description This role supports drug substance and drug product development by executing characterization studies. The role involves performing and analyzing advanced analytical testing to assess critical quality attributes and support formulation development, stability studies, and regulatory submissions.

The incumbent plans and executes experiments, interprets analytical data, and ensures compliance with GLP/GMP and data integrity standards. It contributes to analytical method development, validation, and troubleshooting while supporting specification setting and method transfer activities. The role also ensures proper laboratory operations and documentation, enabling reliable scientific outcomes and supporting decision-making across R&D; characterization programs.

Essential Functions

- Proven experience working in a GMP/GLP-compliant scientific environment.
- Strong knowledge of spectroscopic and biophysical techniques, peptide chemistry, and peptide characterization, with demonstrated expertise in at least one of these areas.
- Experience in related substances/impurity method development and validation for peptide drug products using LC-UV and Amino Acid Analyzer techniques.
- Hands-on experience with SEC-UV, SEC-MALS, SV-AUC, and CE, including data analysis and interpretation, with expertise in at least one of these techniques.
- Experience in the preparation, review, and approval of method development and method validation protocols and reports.
- Sound understanding of ICH guidelines and regulatory requirements applicable to peptide drug products.
- Demonstrated ability to work effectively as a team player in a multidisciplinary environment.
- Flexibility and willingness to work at different locations based on project and team requirements.




- Strong scientific and technical writing skills will be considered an added advantage.

Additional Responsibilities QUALIFICATIONS Education

- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred

Experience:

- 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: About Us Amneal is an equal chance 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.

📌 Senior Officer / Executive, R&D Injectable Peptide Characterization (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad