Associate Director, External Analytical Development & QC

Azalea Therapeutics; Berkeley (CA); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Bonus eligible

Equity eligible

Hybrid work in Berkeley

Job summary

Azalea Therapeutics seeks an Associate Director, Analytical Development / Quality Control to lead external analytical and QC capabilities for EDV and AAV programs. The role ensures assay readiness, testing, release, stability, and regulatory readiness with CRO/CDMO partners and internal teams.

The candidate will manage method transfer, data integrity, risk assessment, and regulatory support while balancing scientific rigor with speed in an early-stage biotech setting.

Qualifications

• Bachelor’s degree with 10+ years of relevant experience; Master’s with 8+ years; PhD with 6+ years (or equivalent).
• Experience in analytical development and/or QC for viral vectors, gene therapies, cell therapies, vaccines, or complex biologics.
• Experience leading analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management.

Responsibilities

• Own external analytical plan across Azalea programs and manage CRO/CDMO partnerships.
• Oversee analytical data, transfer plans, and comparator readouts for regulatory submissions.
• Lead cross-functional collaboration to establish phase-appropriate specifications and data packages.

Skills

Analytical development

Quality control

Vendor management

Education

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

Master’s degree or PhD in a related field

Job description

Azalea Therapeutics seeks an Associate Director, Analytical Development / Quality Control to lead external analytical and QC capabilities for EDV and AAV programs. The role ensures assay readiness, testing, release, stability, and regulatory readiness with CRO/CDMO partners and internal teams.

The candidate will manage method transfer, data integrity, risk assessment, and regulatory support while balancing scientific rigor with speed in an early-stage biotech setting.