Principal Scientist, Analytical Development
Core
Lead analytical development for oligonucleotides and antibody oligo conjugates (AOC) from preclinical through commercial phases, ensuring cGMP compliance and advancing analytical techniques.
Role type
Principal Scientist, Analytical Development
Builds
Drug substance and drug product controls for biopharmaceuticals
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Oligonucleotide and bioconjugate characterization, LC-MS/MS, SEC, IP-RP, AEX, method validation, cGMP compliance, regulatory document authoring, cross-functional CMC strategy
Preferred skills
Postdoc experience, novel concept development, team mentorship, external vendor management
Technologies
LC-MS, MS/MS, SEC, IP-RP, AEX, Capillary Electrophoresis
Responsibilities
Lead analytical methods development and qualification for oligos/AOC; Represent analytical development on cross-functional CMC teams; Authorize CMC regulatory documents; Train lab personnel and support off-site transfers; Contribute to department policies and strategies
Seniority
Principal, hands-on IC with strategic influence
