About this role
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:
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses: