Process Development Senior Scientist
Core
Develop and characterize liquid and lyophilized formulations for biologics, with a focus on ADC drug product formulation, handling, and lab-scale sterile filling to support commercialization and lifecycle management.
Role type
Senior IC process development scientist (ADC/biologics)
Builds
Stable, manufacturable drug products for late-stage biologics and commercial products
Domain
Biotechnology / Oncology / ADC drug development
Deliverable
production ML models | product features
Required skills
ADC drug product formulation, linker-payload stability analysis, drug-to-antibody ratio (DAR) assessment, free drug/payload degradation characterization, liquid and lyophilized formulation development, lab-scale sterile filling, process understanding across unit operations, in-use compatibility evaluation, stability testing under clinical conditions, application of AI/ML for predictive modeling, regulatory document authoring (IND/CTA), technology transfer support
Preferred skills
PhD in Pharmaceutics/Biotechnology/Biochemistry, 2-4 years postdoc or industry experience, experience with CMO/CDMO collaboration, advanced analytical techniques (UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis), regulatory submission experience (CTAs, BLAs)
Technologies
UPLC, HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, subvisible particle analysis, AI/ML platforms
Responsibilities
Design and execute formulation and process development studies; apply scientific principles to solve technical challenges; integrate formulation, stability, and analytical data; author technical documents and control strategies; support technology transfer and batch record reviews; present findings to stakeholders
Seniority
Senior, hands-on IC
