Role Summary
We are looking for professionals with solid experience in Analytical R&D; within an API CDMO/CRAMS workplace . 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