Process Development Associate Scientist - Pre-Pivotal Drug Product Technologies
Core
Design and develop liquid and lyophilized formulations for early-stage biologics (monoclonal antibodies, multispecifics), establish scalable fill/finish processes, and support regulatory submissions.
Role type
Associate Scientist, Process Development (Biologics)
Builds
Early-stage drug product formulations and fill/finish processes for biologics
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Formulation development, fill/finish operations, stability testing, CQA evaluation, DoE, high-throughput experimentation, laboratory automation, data analysis
Preferred skills
Biophysical analysis (light scattering, DSF, AUC, FFF), mass spectrometry, robotic liquid handling, workflow digitization, analytical techniques (UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS)
Technologies
Hamilton, Tecan, Beckman Coulter, Opentrons, electronic data capture systems
Responsibilities
Plan and execute formulation, stability, and fill/finish process studies; develop and characterize liquid and lyophilized formulations; investigate biologics-relevant CQAs; design automated high-throughput screening workflows; implement laboratory automation solutions; author technical protocols and regulatory sections for IND submissions
Seniority
Mid-level, hands-on IC
