Principal Scientist I, Biologics Analytical R&D (External Programs)
Core
Lead analytical strategies and external program execution for early-stage biologic development (mAbs, ADCs) from proof of concept through clinical supply release.
Role type
Principal Scientist, Biologics Analytical R&D (External Programs)
Builds
Robust analytical methods, clinical supply release testing, stability studies, and regulatory submission content for biologic medicines.
Domain
Biopharmaceuticals / Analytical Chemistry / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Protein HPLC (SEC, IEX, HIC), capillary electrophoresis, separation techniques for protein analysis, regulatory document authoring, data trend interpretation, project management, scientific writing, GXP compliance
Preferred skills
Laboratory systems (LIMS, CDS, ELN), statistical analysis (capability analysis, gauge R&R, DOE), leadership of analytical development for biologic compounds
Technologies
HPLC, capillary electrophoresis, LIMS, CDS, ELN
Responsibilities
Develop analytical strategies for formulation and process development studies; Collaborate with third-party laboratories to ensure CMC timelines; Interpret and identify data trends in release and stability assays; Author and review regulatory documents and technical reports; Mentor peers in project management and strategy development; Lead initiatives for continuous improvement in analytical characterization.
Seniority
Principal, hands-on IC with mentorship