Research Associate - Analytical Development
Core
Develop, validate, and transfer analytical methods for complex injectables, hydrogels, and large molecules to support formulation development and scale-up.
Role type
Senior IC analytical development scientist
Builds
Analytical methods, specifications, stability data, and reports for pharmaceutical formulations
Domain
Pharmaceutical manufacturing (CMC/Analytical)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
analytical method development, method validation, method transfer, stability study management, specification writing, literature search, ELN data review, vendor coordination, instrument maintenance
Preferred skills
experience with complex injectables, hydrogels, large molecules, peptides
Technologies
ELN, Coupa, QMS
Responsibilities
Carry out analytical method development and pre-validation; support formulation development, optimization, and scale-up; manage stability study activities; coordinate outside analysis and report review; prepare specifications and analytical protocols; conduct literature searches for regulatory aspects; review ELN experiments and data; support procurement activities; coordinate instrument maintenance
Seniority
Senior, hands-on IC
