AHMEDABAD · FULLTIME
Sr Officer / Executive, R&D Injectable Peptide Characterization
Amneal Pharmaceuticals
Ahmedabad · onsite · Posted 13d ago
Sourced from
Undisclosed5–8 yrsfulltimeAhmedabad
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Section · 01
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 RD 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:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
Method TransferAnalytical Method DevelopmentChemistryMethod DevelopmentMethod ValidationcharacterizationFormulation DevelopmentAnalytical Testinglaboratory operationsoperationsdata analysiscomplianceProduct Development
Section · Company
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
Employees rate it well for
Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65
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