Hybrid Associate Director, External Analytical Development

Valid8 Financial, Inc.; Berkeley (CA); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Bonus/Equity Eligible

Job summary

Azalea Therapeutics is seeking a scientifically rigorous Associate Director, Analytical Development / Quality Control to own external analytical capabilities for EDV and AAV programs. The role reports to the VP of External CMC Operations and requires leadership of CRO/CDMO partners, phase-appropriate strategies, and data integrity for early-phase clinical development.

The position is hybrid, onsite in Berkeley, CA 3–5 days per week, with travel to CRO/CDMOs as needed.

Qualifications

• Bachelor’s degree in analytical chemistry, biochemistry, molecular biology, pharmaceutical sciences, biotechnology, or related field.
• Master’s degree with 8+ years of relevant experience or PhD with 6+ years.
• PhD with >10 years preferred (if applicable to the role).

Responsibilities

• Lead external analytical programs across Azalea programs, including assay scope, validation, and transfer.
• Oversee CROs/CDMOs, ensuring on-time, compliant delivery and data integrity.
• Develop phase-appropriate specifications and data packages for regulatory submissions.
• Coordinate external testing logistics from sample planning to data delivery.
• Mentor internal staff and external partners; manage risks and issues.
• Contribute analytical/ QC content to CMC plans and regulatory materials.

Education

Bachelor’s degree

Master’s degree

PhD

Job description

Azalea Therapeutics is seeking a scientifically rigorous Associate Director, Analytical Development / Quality Control to own external analytical capabilities for EDV and AAV programs. The role reports to the VP of External CMC Operations and requires leadership of CRO/CDMO partners, phase-appropriate strategies, and data integrity for early-phase clinical development.

The position is hybrid, onsite in Berkeley, CA 3–5 days per week, with travel to CRO/CDMOs as needed.