Analytical R&D

Role Summary

We are looking for professionals with strong 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 API development

. Skillset Required: Analytical R&D, API, CDMO/CRAMS Environment, Analytical Method Development, Analytical Method Optimization, Analytical Method Validation, Analytical Method Verification, Analytical Method Transfer, Characterization, Intermediates, Process-Related Compounds, Analytical Development Activities, Early Development, Scale-Up, Commercialization, Analytical Methods, Starting Materials, Impurities, Assay Analysis, Related Substances, Degradation Products, Residual Solvents, Critical Quality Attributes, Forced Degradation, Stability-Indicating Method Development, ICH Requirements, Process Development, Route Scouting, Technology Transfer, Process Impurities, Degradation Impurities, HPLC, UPLC, GC, Headspace GC, UV-Visible Spectrophotometer, Karl Fischer, FTIR, LC-MS, GC-MS, Analytical Instrument Troubleshooting, Analytical Data Review, Data Integrity, GLP, cGMP, Client Requirements, Analytical Protocol Preparation, Method Development Reports, Validation Protocols, Validation Reports, Specifications, Analytical Procedures, Customer Submissions, DMF, Regulatory Packages, OOS Investigation, OOT Investigation, Deviation Investigation, Atypical Results Investigation, Process R&D Coordination, QA, QC, Project Management, CDMO Project Timelines, Technical Discussions, Analytical Inputs