Associate Director, QC Analytical Lifecycle Management
Core
Strategic and technical leadership for GMP analytical activities supporting manufacturing, in-process and final product testing, and analytical method lifecycle management.
Role type
Associate Director, QC Analytical Lifecycle Management
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, laboratory investigations, risk assessments, cross-functional leadership, strategic planning, regulatory compliance (FDA/ICH/Pharmacopeias), data integrity principles, matrix environment decision-making.
Preferred skills
Technology transfer, product introduction, laboratory start-up or readiness, commercial manufacturing, regulatory submissions, inspections, external laboratory oversight.
Technologies
Chromatography, spectroscopy, potency, purity, identity, molecular methods, microbiological methods, cell-based assays
Responsibilities
Lead analytical method transfer, qualification, validation, verification, implementation, troubleshooting, lifecycle management, performance monitoring, continuous improvement, and retirement. Provide technical oversight for complex laboratory investigations, out-of-specification results, and deviations. Establish technical strategies for analytical readiness including instrumentation, reference standards, and data systems. Support regulatory submissions, health authority questions, inspections, and audits. Lead assessments of method performance and laboratory trends to identify risks and implement improvements. Author, review, and approve GMP records, protocols, and validation documentation. Manage program plans, resources, and governance for analytical activities. Provide technical governance and performance oversight for external laboratories.
Seniority
Senior, hands-on IC with management responsibilities