Principal Scientist, Analytical Development (Small Molecule)
Core
Leading analytical development activities for small molecule drug substances from preclinical through commercial phases, establishing and validating testing methods and control strategies.
Role type
Principal Scientist, Analytical Development (Small Molecule)
Builds
Drug substance characterization methods and control strategies for preclinical to commercial drug development
Domain
Biopharmaceuticals / Small Molecule Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry expertise, Process chemistry understanding, Method development/validation/transfer, cGMP compliance, LC/GC/IR/MS/NMR/KF/UV proficiency, Project management, Laboratory supervision
Preferred skills
Cross-functional collaboration, Strategic policy development, Technical mentorship
Technologies
LC, GC, IR, MS, NMR, KF, UV
Responsibilities
Plan and manage analytical development projects; Design and execute analytical chemistry activities; Supervise laboratory work and personnel; Optimize analytical methods for API development; Provide input into CMC regulatory documentation; Support off-site analytical transfers and manufacturing support
Seniority
Principal, hands-on IC with leadership of lower levels
