Senior Scientist, CMC Downstream Process Development
Core
Lead downstream process development for antibody and bioconjugate assets from preclinical to commercialization, focusing on purification, scale-up, and technology transfer.
Role type
Senior Scientist/Engineer, Biologics Downstream Process Development
Builds
Antibody and bioconjugate therapeutics (mAbs, bispecifics, APCs, AOCs)
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
downstream processing unit operations, chromatography (affinity, IEX, HIC), membrane-based separation, column-packing, bioprocessing equipment operation, process scale-up strategies, laboratory productivity, protein characterization, analytical techniques, DOE and statistical data analysis, cGMP knowledge
Preferred skills
APC/AOC/siRNA/AAV experience, external manufacturing partner experience, high-throughout platform experience (e.g., Tecan), protein characterization and analytical techniques, DOE and statistical data analysis, cGMP requirements
Technologies
AKTA, Repligen systems, Tecan, SEC, SDS-PAGE, CE, ciEF
Responsibilities
Design and execute scalable purification processes, select and optimize chromatography resins and modalities, support process scale-up and technology transfer, author and review protocols and technical reports, perform troubleshooting activities, mentor junior scientists
Seniority
Senior, hands-on IC with mentorship responsibilities
