VP, External CMC Operations & CDMO Strategy

Valid8 Financial, Inc.; Berkeley (CA); On-site; USD 270,000 - 315,000; Full time

Job summary

Azalea Therapeutics seeks a Vice President of External CMC Operations to lead external manufacturing strategy and CDMO partnerships, ensuring seamless tech transfer and alignment with IND/clinical milestones. You will oversee timelines, budgets, and regulatory readiness while coordinating cross-functional teams across development, regulatory, and supply chain.

The role requires deep CMC execution expertise, viral vector manufacturing experience, and a hands-on leadership style suited to

Qualifications

• 12+ years in CMC development or manufacturing within biotech or gene therapy.
• Experience managing external manufacturing programs and CDMOs.
• Proven leadership building MSAT/AD/QC and manufacturing capabilities for Phase 1 clinical trials and beyond.

Responsibilities

• Develop and execute Azalea's external CMC strategy across all programs.
• Manage CDMO partnerships, budgets, tech transfer, and governance.
• Coordinate cross-functional teams to align CMC timelines with regulatory milestones.
• Lead team building for MSAT, AD/QC, and Supply Chain.

Skills

CMC leadership

CDMO management

External manufacturing

Viral vector manufacturing

Program management

Education

MS/PhD in relevant field

Job description

Azalea Therapeutics seeks a Vice President of External CMC Operations to lead external manufacturing strategy and CDMO partnerships, ensuring seamless tech transfer and alignment with IND/clinical milestones. You will oversee timelines, budgets, and regulatory readiness while coordinating cross-functional teams across development, regulatory, and supply chain.

The role requires deep CMC execution expertise, viral vector manufacturing experience, and a hands-on leadership style suited to