Principal Research Scientist II
Core
Oversee laboratory activities and lead the analytical characterization of late-stage biologics compounds (monoclonal antibodies, ADCs, bispecific antibodies) to ensure methods are fit for commercial QC and regulatory submission.
Role type
Senior IC Principal Research Scientist (Biologics Analytical)
Builds
Robust analytical methods, comprehensive data packages, and approvable marketing application content for commercialization.
Domain
Biopharmaceuticals / Analytical Chemistry / Biologics
Required skills
Method validation, GMP environment operations, Laboratory management, Protein chemistry, Biochemistry, Technical writing, Regulatory documentation, Project management, Data analysis, Team leadership
Preferred skills
Analytical Quality by Design (AQbD), Protein HPLC (SEC, IEX, HIC), Capillary electrophoresis, Investigation of OOS/OOT events
Technologies
HPLC, Capillary Electrophoresis, GMP systems
Responsibilities
Provide leadership and talent development for a team of scientists, Lead analytical characterization of late-stage biologics, Demonstrate critical mindset for method troubleshooting, Manage lab activities and standards, Author technical and regulatory documents, Organize and present scientific plans and data
Seniority
Principal, hands-on IC with management responsibilities
