Sr Associate Scientist, FPD
Core
Develop formulation and drug product processes for innovative biologics molecules to advance medicines into the clinic.
Role type
Senior Associate Scientist (Biologics CMC)
Builds
Formulation and Drug Product manufacturing processes for monoclonal antibodies, bispecifics, ADCs, and fusion proteins
Domain
Biopharmaceuticals / Biologics CMC
Required skills
Biologics CMC development, formulation development, Drug Product process development, clinical in-use evaluation, analytical characterization, biophysical characterization, hands-on laboratory execution, technical documentation, data analysis, cross-functional collaboration
Preferred skills
Experience with monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins
Technologies
Lab notebooks, regulatory dossiers, protocols, reports
Responsibilities
Design and execute experiments for formulation and drug process development; lead lab executions; document data following GxP practices; author technical documents and regulatory dossiers; analyze data and draft conclusions; collaborate with internal and external stakeholders; support regulatory filings and cross-functional teams.
Seniority
Senior, hands-on IC
