Technical Development Principle Scientist
Core
Design and execute analytical studies to support process development and enable regulatory filings for clinical biologic therapeutics.
Role type
Principal Scientist, Analytical Development (CMC)
Builds
Biologic therapeutics for clinical trials and commercial launch
Domain
Biopharmaceuticals / Analytical Chemistry / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry fundamentals, protein characterization, HPLC, LC-MS, capillary electrophoresis, advanced spectroscopy, CMC development knowledge
Preferred skills
Small molecule linker drugs, antibody-drug conjugates (ADCs), IND-enabling and BLA-enabling activities
Technologies
HPLC, LC-MS, capillary electrophoresis, advanced spectroscopy
Responsibilities
Design and execute analytical studies, support process development, enable regulatory filings (IND, BLA), present data at internal and external meetings
Seniority
Senior, hands-on IC
