Vice President, External CMC Operations

Azalea Therapeutics, Inc.•Berkeley, CA

3d•$270,000 - $315,000•Onsite

About The Position

Azalea is seeking a Vice President, External CMC Operations to lead the strategy and execution of external manufacturing and CMC activities including the development of its lead program toward first-in-human studies, further development of the first program during clinical phases, and development of additional programs into the clinical pipeline. This role will be responsible for building and managing Azalea’s external manufacturing ecosystem, including Contract Development and Manufacturing Organizations (CDMO) relationships, timelines, process transfer, and operational coordination across process development, analytical development, quality, regulatory, supply chain and clinical teams. The Vice President, External CMC Operations will play a central role in ensuring Azalea’s programs progress efficiently from early development through GMP manufacturing readiness, aligning external partners with internal program timelines and regulatory milestones, and delivering clinical supply to patients across global clinical sites. This position is ideal for a hands-on leader with deep expertise in CMC execution, viral-vector manufacturing, and CDMO management, who thrives in early-stage biotech environments and enjoys translating complex science into manufacturable therapies.

Requirements

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.

Nice To Haves

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.

Responsibilities

Develop and execute Azalea’s 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.
Identify, select, and manage CDMO partners responsible for process development, analytical development, and GMP manufacturing.
Establish governance structures and communication processes with external partners.
Monitor CDMO performance to ensure timelines, quality standards, and technical and reporting objectives are achieved on schedule.
Assess program risks and potential mitigation approaches arising from CDMO efforts and communicate effectively to internal teams and leadership.
Evaluate external CDMO budget and impacts on budget from change orders or new agreements on a regular cadence and report to leadership and finance.
Develop and maintain integrated CMC timelines aligned with overall program milestones.
Coordinate closely with internal teams across research, technical development, regulatory, and clinical functions.
Oversee technology transfer of manufacturing processes to external manufacturing partners.
Ensure processes are robust, scalable, and ready for clinical manufacturing.
Evaluate external CDMO capabilities for feasibility and manufacturability of novel delivery technologies, including next-generation platform formats.
Lead feasibility assessments at CDMOs to de-risk new manufacturing processes ahead of formal tech transfer and scale-up.
Inform strategic decisions on internal vs. external development of emerging platform technologies based on CDMO capability gaps, timelines, and cost.
Support transition from development to engineering runs and GMP manufacturing.
Ensure manufacturing plans support regulatory submissions and clinical timelines.
Lead external CMC operations across all active programs, ensuring each program has a clear manufacturing strategy, timeline, budget, and CDMO tech transfer plan.
Partner with Research, Quality, Regulatory, and Clinical teams to align external manufacturing activities with program-specific development milestones.
Provide strategic oversight as the portfolio expands, adapting the external manufacturing network to support multiple concurrent programs at different stages of development.
Build and lead the External CMC Operations function, with anticipated direct reports for functions including MSAT, AD/QC, and Supply Chain management.
Recruit, onboard, and develop team members as programs advance toward GMP manufacturing and clinical milestones.
Define clear operational interfaces between external CMC operations and internal CMC/technical development teams to ensure seamless coordination across programs.
Foster a collaborative, high-accountability culture aligned with the pace and rigor of an early-stage biotech advancing toward first-in-human studies.
Proactively assess and scale the organization beyond as the pipeline needs grow further working within the business constraints.