Director of Analytical QC & Method Lifecycle

Avid Bioservices; Tustin (CA); Sur place; USD 163 000 - 204 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) matching

Paid time off

Résumé du poste

Avid Bioservices seeks a Director, Quality Control Analytical Sciences and Technology to provide scientific and strategic leadership for analytical method lifecycle management within Quality Control. You will oversee governance of analytical control strategies and act as escalation point for complex investigations.

You will lead method changes, revisions, and continuous improvement, partnering with QC Operations, Analytical Development, MS&T, QA, and Regulatory Affairs.

Qualifications

• Experience in analytical testing, writing reports/procedures/specifications, GMPs and regulatory audits.
• Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines.

Responsabilités

• Provide strategic oversight of GMP analytical methods throughout their operational lifecycle to ensure methods remain fit-for-purpose, compliant, and aligned with product and business needs.
• Lead root cause analyses involving methods, instrumentation, reagents, standards, training, and laboratory systems.
• Establish a proactive analytical monitoring program that uses data and statistical tools to ensure continued assay control and detect emerging risks.
• Build and lead a high-performing scientific organization that provides advanced technical support to QC Operations and the broader business.
• Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings.

Formation

B.S. in Chemistry, Biochemistry, or Biology or related field

Description du poste

Avid Bioservices seeks a Director, Quality Control Analytical Sciences and Technology to provide scientific and strategic leadership for analytical method lifecycle management within Quality Control. You will oversee governance of analytical control strategies and act as escalation point for complex investigations.

You will lead method changes, revisions, and continuous improvement, partnering with QC Operations, Analytical Development, MS&T, QA, and Regulatory Affairs.