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Salary: USD 270,000 - 315,000 / annual
Azalea Therapeutics is pioneering precision genome engineering directly inside the body to create cancer immunotherapies in vivo. The company uses Enveloped Delivery Vehicles (EDVs) to locate T cells within patients and deliver genome engineering cargo, enabling cell therapy that is faster and more accessible by avoiding complex external manufacturing.
The Vice President, External CMC Operations will lead the strategy and execution of external manufacturing and CMC (Chemistry, Manufacturing, and Controls) activities across Azalea's pipeline. This role is responsible for building and managing Azalea's external manufacturing ecosystem, including Contract Development and Manufacturing Organizations (CDMO) relationships, process transfer, timelines, and operational coordination across process development, analytical development, quality, regulatory, supply chain, and clinical teams.
Key responsibilities include:
**External CMC Strategy & Execution**: Develop and execute CMC and manufacturing strategy across all programs. Ensure alignment between manufacturing timelines, regulatory milestones, and program development plans. Provide strategic guidance on manufacturing readiness as programs move toward IND-enabling studies and clinical development. Ensure supply to patients across global clinical sites.
**CDMO Oversight & Vendor Management**: Identify, select, and manage CDMO partners. Establish governance structures and communication processes. Monitor CDMO performance against timelines, quality standards, and technical objectives. Assess program risks and mitigation approaches. Evaluate external CDMO budgets and impacts from change orders on a regular cadence.
**Manufacturing Timeline & Program Coordination**: Develop and maintain integrated CMC timelines aligned with overall program milestones. Coordinate closely with internal teams across research, technical development, regulatory, and clinical functions.
**Process Development & Technology Transfer**: Oversee technology transfer of manufacturing processes to external partners. Ensure processes are robust, scalable, and ready for clinical manufacturing. Evaluate external CDMO capabilities for feasibility and manufacturability of novel delivery technologies. Lead feasibility assessments to de-risk new manufacturing processes ahead of formal tech transfer and scale-up.
**GMP Manufacturing Readiness**: Support transition from development to engineering runs and GMP manufacturing. Ensure manufacturing plans support regulatory submissions and clinical timelines.
**Cross-Functional & Multi-Program Leadership**: Lead external CMC operations across all active programs. Partner with Research, Quality, Regulatory, and Clinical teams. Provide strategic oversight as the portfolio expands.
**Team Building & Leadership**: Build and lead the External CMC Operations function with anticipated direct reports for MSAT, AD/QC, and Supply Chain management. Recruit, onboard, and develop team members. Define clear operational interfaces between external CMC operations and internal teams. Foster a collaborative, high-accountability culture.
Working conditions include up to 20% travel to CDMO partners or manufacturing sites, with a combination of office and occasional manufacturing-site visits.
**Requirements**
Minimum Qualifications:
- M.S. or Ph.D. or equivalent in bioengineering, chemical engineering, molecular biology, biochemistry, or related field
- 12+ years of experience in CMC development, technical operations, or manufacturing within biotechnology or gene therapy
- Demonstrated experience managing external manufacturing programs and CDMOs
- Proven experience supporting programs from discovery through IND-enabling development and early clinical manufacturing
- Proven leadership experience with building and scaling MSAT, AD/QC, and/or Manufacturing capabilities for Phase 1 clinical trials and beyond
- Successful track record of building, mentoring, and scaling high-performing technical teams
Preferred Qualifications:
- Direct experience with viral vector manufacturing (AAV, lentivirus, or similar platforms)
- Experience working in early-stage biotech companies transitioning programs toward first-in-human studies
- Strong understanding of regulatory expectations for CMC packages supporting IND submissions
- Experience managing complex technical programs involving multiple external partners
