Associate Director, External Analytical Development

Socket.dev; Berkeley (CA); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Bonus/Equity eligible

Job summary

Azalea Therapeutics in Berkeley, CA is seeking an Associate Director, Analytical Development / Quality Control to own external analytical and QC capabilities for advancing EDV and AAV programs. The role reports to the VP, External CMC Operations in a hybrid onsite setting.

The candidate will establish phase-appropriate analytical strategies, manage CRO/CDMO partnerships, and ensure regulatory compliance for early-phase clinical trials, with emphasis on method transfer and data integrity.

Qualifications

• Bachelor’s degree in analytical chemistry or related field required.
• Experience leading analytical method development and transfer in GMP environment.
• Experience supporting regulatory submissions and health authority interactions.

Responsibilities

• Own the integrated external analytical plan across Azalea programs.
• Lead external CRO/CDMO management and oversight.
• Coordinate method transfer, validation, and lifecycle management.
• Collaborate with Quality, Regulatory, and MSAT to define specifications.
• Review data packages and reports for regulatory readiness.

Skills

Analytical thinking

External collaboration

Cross-functional leadership

Regulatory understanding

Data interpretation

Education

Bachelor’s degree in analytical chemistry / biochemistry / molecular biology / pharmaceutical sciences / biotechnology or related

Master’s degree with 8+ years or PhD with 6+ years

Tools

qPCR

ddPCR

ELISA

HPLC/UPLC

Capillary electrophoresis

Job description

Azalea Therapeutics in Berkeley, CA is seeking an Associate Director, Analytical Development / Quality Control to own external analytical and QC capabilities for advancing EDV and AAV programs. The role reports to the VP, External CMC Operations in a hybrid onsite setting.

The candidate will establish phase-appropriate analytical strategies, manage CRO/CDMO partnerships, and ensure regulatory compliance for early-phase clinical trials, with emphasis on method transfer and data integrity.