Director, QC Analytics & Method Lifecycle

avidbio; Tustin (CA); On-site; USD 163,000 - 204,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices is seeking a Director, Quality Control Analytical Sciences and Technology to lead the analytical method lifecycle within QC. You will provide scientific and strategic direction to ensure methods remain fit-for-purpose throughout their lifecycle and drive data-driven performance monitoring.

You will serve as the escalation point for complex OOS/OOT investigations, adverse trends, and method performance risks, and partner with QC Operations, Analytical Development, QA, Regulatory

Qualifications

• B.S. in Chemistry, Biochemistry, or Biology with 10+ years in QC/analytical lab.
• MS or higher degree preferred.
• Knowledge of FDA guidelines, USP, EP, EU Annexes, and ICH guidelines.

Responsibilities

• Oversee analytical method lifecycle governance.
• Lead investigations of OOS/OOT and method performance risks.
• Provide data-driven monitoring and trend analysis.
• Partner with QC Operations, Analytical Development, QA, Regulatory Affairs, and clients.

Skills

Leadership

Strategic thinking

Cross-functional collaboration

Communication

Education

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

MS or higher degree preferred

Job description

Avid Bioservices is seeking a Director, Quality Control Analytical Sciences and Technology to lead the analytical method lifecycle within QC. You will provide scientific and strategic direction to ensure methods remain fit-for-purpose throughout their lifecycle and drive data-driven performance monitoring.

You will serve as the escalation point for complex OOS/OOT investigations, adverse trends, and method performance risks, and partner with QC Operations, Analytical Development, QA, Regulatory