VP, External CMC Ops — Scale Biotech Manufacturing

Azalea Therapeutics; Berkeley (CA); On-site; USD 270,000 - 315,000; Full time

Job summary

Azalea Therapeutics is seeking a Vice President, External CMC Operations in Berkeley, CA to lead strategy and execution of external manufacturing and CMC activities. You will coordinate process transfer, CDMO relationships, and cross-functional teams to prepare programs for IND-enabling studies and clinical development.

The role requires deep expertise in CMC execution, viral-vector manufacturing, and CDMO management, with a hands-on leadership style suitable for an early-stage biotech

Qualifications

• 12+ years of experience in CMC development, technical operations, or manufacturing in biotech or gene therapy.
• Proven experience managing external manufacturing programs and CDMOs.
• Leadership experience building MSAT/AD/QC and manufacturing capabilities for early trials.
• Direct experience with viral vector manufacturing (AAV, lentivirus, or similar) preferred.

Responsibilities

• Develop and execute Azalea's external CMC strategy and manufacturing plan across programs.
• Manage CDMO partners, governance structures, and budget reporting.
• Maintain integrated CMC timelines aligned with program milestones and regulatory needs.
• Lead technology transfer and process development activities to support GMP readiness.

Skills

Leadership

CDMO management

CMC strategy

Education

MS/PhD in bioengineering/chemical engineering/biochemistry

Job description

Azalea Therapeutics is seeking a Vice President, External CMC Operations in Berkeley, CA to lead strategy and execution of external manufacturing and CMC activities. You will coordinate process transfer, CDMO relationships, and cross-functional teams to prepare programs for IND-enabling studies and clinical development.

The role requires deep expertise in CMC execution, viral-vector manufacturing, and CDMO management, with a hands-on leadership style suitable for an early-stage biotech