Principal Scientist, Analytical Lifecycle Management
Core
Lead Quality Control (QC) strategy for late-stage biologics programs, ensuring registration and commercialization readiness through integrated analytical lifecycle management.
Role type
Principal Scientist, Analytical Lifecycle Management (QC Lead)
Builds
Late-stage biologics drug substance and drug product programs
Domain
Biopharmaceuticals / Biologics / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method establishment and validation, specification setting, stability and shelf-life strategy, reference standard strategy, regulatory submission authorship, cross-functional influence, risk-based decision-making, external partner oversight (CDMOs/CTLs), technical mentorship
Preferred skills
GMP-regulated environment experience, late-stage biologics QC strategy leadership, global GMP/ICH guidance knowledge, comparability package documentation, Mandarin language proficiency
Technologies
GMP, ICH guidelines, CMC documentation
Responsibilities
Serve as primary QC representative on cross-functional CMC teams; drive integrated QC program strategy across analytical lifecycle; lead authorship of regulatory submissions; oversee external partners (CDMOs/CTLs); resolve complex technical and compliance issues; provide technical mentorship to matrixed colleagues; provide strategic oversight of laboratory-based activities
Seniority
Principal, strategy & mentorship
