Process Development Engineer II - Synthetic and Bioconjugation Scale-Up Technologies (SBST)
Core
Design and develop scalable, robust, GMP-ready bioconjugation and purification processes for proteins conjugated to synthetic molecules, supporting technology transfer to CDMOs and Regeneron manufacturing suites.
Role type
Process Development Engineer II (Bioconjugation & Scale-Up)
Builds
GMP-ready manufacturing workflows for bioconjugated therapeutics
Domain
Biopharmaceuticals / Protein Bioconjugation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Bioconjugation process design (lysine/cysteine/site-specific), Downstream purification (chromatography, ultrafiltration/diafiltration, membrane tech), Analytical characterization (HPLC, MS, electrophoresis, UV), Statistical DOE, Technology transfer, GMP principles
Preferred skills
Antibody bioconjugates experience, Predictive process modeling, PAT development
Technologies
HPLC, Mass Spectrometry, Electrophoresis, Ultrafiltration/Diafiltration, Membrane technologies
Responsibilities
Design scalable GMP-ready bioconjugation and purification processes; Optimize processes using statistical DOE; Support technology transfer to CDMOs and internal manufacturing; Collaborate with analytical groups to establish characterization techniques; Author technology transfer and regulatory documentation; Mentor junior team members
Seniority
Mid-level, hands-on IC
