Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies
Core
Design and develop liquid and lyophilized formulations for biologics (monoclonal antibodies, multispecifics) and establish robust, scalable fill/finish processes for early-stage drug products.
Role type
Senior IC process development scientist (biologics formulation)
Builds
Liquid and lyophilized biologics drug products for clinical manufacturing
Domain
Biopharmaceuticals / Biologics
Required skills
Biologics drug product formulation, fill/finish process development, stability testing, high-throughput formulation screening, laboratory automation (robotic liquid handling), design of experiments (DoE), analytical biophysics (UPLC/HPLC, SEC, IEX, CE-SDS), regulatory documentation, technology transfer
Preferred skills
AI/ML for R&D optimization, workflow digitization, clinical-stage manufacturability, protein degradation/quality attributes expertise, CMO/CDMO collaboration
Technologies
Hamilton, Tecan, Beckman Coulter, Opentrons, LLMs, in silico tools
Responsibilities
Plan and execute formulation and fill/finish process studies; develop and characterize liquid and lyophilized formulations; build process understanding across unit operations; evaluate in-use compatibility and stability; investigate biologics-relevant CQAs; design automated high-throughput screening workflows; implement laboratory automation solutions; author regulatory submissions and tech transfer packages; support technology transfer to CMOs/CDMOs.
Seniority
Senior, hands-on IC
