Process Development Principal Scientist – Drug Product Technologies
Core
Lead early-stage drug product development for complex biologics including ADCs and oligonucleotides, designing formulations and establishing scalable processes.
Role type
Principal Scientist, Biologics Drug Product Technologies
Builds
Liquid and lyophilized formulations, fill/finish processes, and regulatory submissions for clinical development
Domain
Biotechnology / Biologics
Deliverable
production ML models | product features
Required skills
Biologics drug product formulation, process development, analytical characterization, stability assessment, technology transfer, regulatory authoring, cross-functional collaboration, data-driven formulation screening, machine learning/AI application, first-principles thinking
Preferred skills
ADC development, oligonucleotide/siRNA development, linker-payload integrity analysis, degradation pathway investigation, high-throughput screening, CMO/CDMO collaboration
Technologies
UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, LC-MS
Responsibilities
Design and develop liquid and lyophilized formulations for complex biologics; evaluate critical quality attributes (CQAs) and stability; establish robust, scalable fill/finish processes; author regulatory submissions; mentor junior scientists; support technology transfer to manufacturing partners; apply AI/ML for predictive modeling and workflow acceleration.
Seniority
Principal, hands-on IC with leadership
