Senior / Principal Scientist, Formulation and Drug Product Development
Core
Lead formulation and drug product development for antibody-drug conjugates (ADCs) and biologics, focusing on late-stage clinical programs, regulatory submissions, and commercial launch readiness.
Role type
Senior / Principal Scientist, Formulation and Drug Product Development
Builds
Commercial-ready liquid and lyophilized biologics and ADC drug products
Domain
Biopharmaceuticals / Oncology / ADCs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (drug product formulations and manufacturing processes)
Required skills
Lyophilization process development, comparability assessments, control strategy development, technology transfer, regulatory submission authoring (IND/BLA), CDMO management, sterile manufacturing knowledge, stability characterization, process validation
Preferred skills
Experience with gamma secretase inhibitors or ROR1/FAP targets, QbD principles, emerging formulation technologies
Technologies
Lyophilization equipment, analytical characterization tools, regulatory submission platforms
Responsibilities
Lead formulation screening, optimization, and stability characterization for ADCs; Drive process scale-up and transfer to ensure manufacturability; Establish NORs, PARs, and control strategies; Author regulatory submission sections and comparability assessments; Mentor junior scientists and build internal capabilities
Seniority
Senior / Principal, hands-on IC with strategic leadership
