Senior Officer / Executive, R&D Injectable Peptide Characterization

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India is seeking an experienced scientist to support drug substance and drug product development by executing characterization studies and advanced analytical testing. The role focuses on assessing critical quality attributes and supporting formulation development, stability studies, and regulatory submissions.

You will plan and run experiments, interpret analytical data, and ensure GLP/GMP compliance and data integrity.

Qualifications

• GLP/GMP-compliant laboratory experience in drug development.
• Experience with peptide drug product analysis and related substances.
• Hands-on method development and validation experience.
• Knowledge of ICH guidelines and regulatory requirements.

Responsibilities

• Execute characterization studies and advanced analytical testing for peptide drugs.
• Develop, validate and transfer analytical methods; support regulatory submissions.
• Ensure data integrity and GLP/GMP compliance in the lab.
• Collaborate across multidisciplinary teams to support development programs.

Skills

GMP/GLP compliance

Spectroscopic techniques

Peptide chemistry

LC-UV

Amino Acid Analyzer

SEC-UV

SEC-MALS

SV-AUC

Capillary Electrophoresis

Method development & validation

ICH guidelines

Team collaboration

Flexibility to work at multiple sites

Scientific writing

Education

B. Pharm

M. Pharm

Tools

Amino Acid Analyzer

LC-UV

SEC-UV

SEC-MALS

SV-AUC

Capillary Electrophoresis

Job description

JOB DESCRIPTION

The 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.

Education

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

Experience

• 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.