Associate Director, QC Analytical Lifecycle Management
Core
Provides strategic and technical leadership for GMP analytical activities supporting manufacturing, in-process and final product testing, and analytical method lifecycle management.
Role type
Senior IC analytical lifecycle management lead (Associate Director)
Builds
Robust, phase-appropriate, and compliant analytical capabilities for raw materials, in-process samples, release testing, stability testing, and characterization.
Domain
Biopharmaceutical / Pharmaceutical Quality Control
Required skills
GMP analytical testing, analytical method lifecycle management, method transfer, qualification, validation, verification, implementation, troubleshooting, performance monitoring, continuous improvement, laboratory investigations, risk assessments, data integrity principles, regulatory compliance (FDA/ICH/pharmacopeias), cross-functional leadership, technical strategy development, external laboratory governance.
Preferred skills
Advanced degree (MS/PhD), experience in biotechnology or medical device sectors, deep expertise in specific analytical areas (chromatography, spectroscopy, potency, purity, molecular methods, microbiological methods, cell-based assays).
Technologies
HPLC, GC, Mass Spectrometry, Spectrophotometry, Cell-based assay platforms, LIMS, Data integrity systems.
Responsibilities
Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement. Provide technical oversight and scientific direction for complex laboratory investigations, out-of-specification results, and method-related deviations. Establish technical strategies for analytical readiness including instrumentation, reference standards, reagents, methods, and data systems. Author, review, and approve protocols, reports, procedures, and validation documentation. Support regulatory submissions, health authority inspections, and internal/external quality audits. Manage program plans, priorities, resources, and governance to align with manufacturing schedules. Lead and develop analytical technical operations professionals.
Seniority
Senior, hands-on IC with management responsibilities
