Analytical Development Scientist
Core
Supporting technical operations for analytical development and testing of sustained release drug products (polymer drug delivery systems) to support ongoing and new programs.
Role type
Analytical Development Scientist
Builds
Polymer-based micro-sphere technology for targeted drug delivery
Domain
Biotechnology / Pharmaceutical / Drug Delivery Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, Method validation, Stability study design, Data analysis, Technical writing, Protocol preparation, SOP writing, GMP compliance, HPLC operation, Rheometer operation, Particle size analysis, USP Dissolution testing, Thermal analysis
Preferred skills
ICH guidelines knowledge, FDA guidelines knowledge, USP guidelines knowledge
Technologies
HPLC (RP, SEC), Rheometer, Particle Size Analyzer, USP Dissolution systems, Thermal analysis equipment
Responsibilities
Support analytical development activities including initial lab assessments, method development, and troubleshooting; Support stability programs including protocol drafting, report writing, and data trending; Prepare and review analytical protocols and reports (validation, development, stability); Perform data analysis and interpretation to support development and regulatory activities; Support coordination of analytical activities with CDMOs and internal teams; Assist with SOP writing, revisions, and document lifecycle management
Seniority
Mid-level, hands-on IC