Description
Description:
Analytical Development - Injectable / Complex Injectable
The position supports peptide and oligonucleotide drug substance (DS) and drug product (DP) development through the development, optimization, validation, transfer, and application of advanced analytical methods to evaluate critical quality attributes (CQAs). The role contributes to product development across sterile and non-sterile dosage forms by performing physicochemical, structural, purity, impurity, identity, potency, and performance-indicating analyses to ensure product quality, comparability, and alignment with regulatory and reference product expectations. The role involves designing and executing analytical studies for process development, formulation development, characterization, forced degradation, stability, compatibility, and batch evaluation, while establishing scientifically justified specifications. The position ensures laboratory readiness, equipment qualification, analytical data integrity, and compliance with cGMP and global regulatory expectations to support regulatory submissions.



The role also supports analytical method transfer, technical investigations, commercial manufacturing troubleshooting, lifecycle management, and the application of advanced analytical and computational tools—including chromatography, mass spectrometry, spectroscopy, and biophysical characterization—to generate scientific insights, enable informed decision-making, and drive innovation in peptide and oligonucleotide development.

Key enhancements specific to peptides and oligonucleotides:
- Includes structural characterization (sequence confirmation, molecular integrity).
- Emphasizes purity, potency, and impurity profiling (truncated sequences, deletion products, deamidation, oxidation, aggregates).
- Covers forced degradation, stability, and comparability studies.
- Mentions advanced analytical platforms such as LC-MS/MS, HRMS, ion-pair RP-HPLC, IEX, SEC, CE, UV, CD, and biophysical tec

📌 Senior Executive, Analytical R&D Injectable (Ahmedabad)
🏢 Amneal
📍 Ahmedabad