Process Development Engineer I - Synthetic and Bioconjugation Scale-Up Technologies (SBST)
Core
Develop manufacturing processes for synthetic small-molecules and bioconjugates used in therapeutic modalities, focusing on GMP production, scale-up, and technology transfer to CDMOs.
Role type
Process Development Engineer I (Synthetic Chemistry)
Builds
GMP-ready manufacturing processes for synthetic small-molecules and bioconjugates
Domain
Pharmaceutical manufacturing / Synthetic chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Organic molecule synthesis, purification techniques (crystallization, extraction, chromatography), statistical design of experiments (DOE), process scale-up, technology transfer, analytical characterization (mass spectrometry, NMR, IR, HPLC), regulatory guidelines (ICH)
Preferred skills
Bioconjugates experience, highly potent compound handling, cross-functional CMC team collaboration, authoring publications/patents
Technologies
Mass spectrometry, NMR, IR spectroscopy, HPLC
Responsibilities
Design and develop scalable GMP-ready processes for synthetic small molecules, optimize reaction parameters and purification operations using DOE, transfer processes to CDMOs for GMP production, author technology transfer and regulatory documentation, mentor junior team members
Seniority
Junior, hands-on IC