Role Summary
We are looking for professionals with solid experience in Analytical R&D; within an API CDMO/CRAMS environment . The role will be responsible for analytical method development, optimization, validation and characterization of API, intermediates and process-related compounds for customer-driven development projects.

Key Responsibilities
- Execute analytical development activities for API CDMO customer projects from early development through scale-up and commercialization.
- Develop and optimize analytical methods for API, intermediates, starting materials and impurities.
- Perform analysis for assay, related substances, degradation products, residual solvents and other critical quality attributes.
- Conduct forced degradation and stability-indicating method development.
- Perform analytical method validation, verification and transfer as per ICH requirements.
- Support process development, route scouting, scale-up and technology transfer activities.
- Characterize and monitor process impurities and degradation impurities.




- Operate and troubleshoot analytical instruments including HPLC/UPLC, GC/GC-HS, KF, UV, FTIR, LC-MS/GC-MS, as applicable.
- Review analytical data and ensure compliance with data integrity, GLP/cGMP and client requirements.
- Prepare analytical protocols, method development reports, validation protocols/reports, specifications and analytical procedures.
- Support preparation of analytical documentation for customer submissions, DMF and regulatory packages, wherever applicable.
- Investigate analytical issues such as OOS, OOT, deviations and atypical results.
- Coordinate with Process R&D;, QA, QC and Project Management to meet CDMO project timelines.
- Participate in technical discussions with customers and provide analytical inputs for project execution.

Instruments / Techniques
- HPLC / UPLC
- GC / Headspace GC
- UV-Visible Spectrophotometer
- Karl Fischer
- FTIR
- LC-MS / GC-MS – preferred
- Other analytical techniques relevant to

📌 Analytical R&D (Hyderabad)
🏢 Talental Consultings
📍 Hyderabad