Senior Principal Research Scientist / Principal Research Scientist II
Core
Lead process research and development of drug conjugates, peptides, and small molecules from pre-clinical through early clinical phases, translating lab processes to scalable cGMP manufacturing.
Role type
Senior Principal Research Scientist / Principal Research Scientist II (Process Chemistry)
Builds
Scalable cGMP manufacturing processes for synthetic molecules
Domain
Biopharmaceuticals / Process Chemistry / Synthetic Molecules
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Organic chemistry, mechanistic theory, control strategy development, mutagenic impurity control, nitrosamine controls, regulatory starting material strategies, team leadership, cross-functional collaboration
Preferred skills
siRNA, antibody drug-conjugates, oligonucleotide-conjugates (AOCs), high-potent compounds, global regulatory expectations, authoring development reports and regulatory filings
Technologies
cGMP manufacturing, mutagenic impurity control, nitrosamine controls
Responsibilities
Lead the setting and implementation of Process Chemistry strategy, lead project teams in process development and characterization, develop and characterize processes in the laboratory and translate them to scalable processes, mentor staff in troubleshooting strategic and experimental issues, author and review key regulatory documents and technical memos, identify and nurture ideas for continuous improvement activities
Seniority
Senior, hands-on IC with strategic leadership