Vice President, External CMC Operations

Job Title: Vice President, External CMC Operations Department: CMC Operations Reports to: CEO Location: Berkeley, California Employment Type: Full time FLSA Status: Exempt About Azalea Azalea Therapeutics is enabling precision genome engineering directly inside the body, with an initial focus on creating cancer immunotherapies in vivo . Azalea is pioneering a new way to turn a person’s own T cells into a powerful cancer therapy — directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing tools to engineer T cells where they already live. At the center of our approach are Enveloped Delivery Vehicles, or EDVs. As highly selective couriers, EDVs are designed to specifically locate T cells within the patient and deliver our genome engineering cargo. Once inside the cell, the anti-cancer agent is inserted into a precise site in the genome, ensuring safe and potent modifications to fortify the T cells against cancers. Why this matters: We aim to make cell therapy faster and more accessible by avoiding complex manufacturing outside the body. Our platform is designed for precision, so the right cells are safely programmed to effectively fight cancer. This technology has the potential to treat a wide range of cancers with a streamlined, scalable process. Our goal is simple: develop next-generation delivery technologies to bring genetic engineering and cell therapies to more patients. The Opportunity 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. Key Responsibilities External CMC Strategy and Execution 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. CDMO Oversight and Vendor Management 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. Manufacturing Timeline and 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 and Technology Transfer 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. GMP Manufacturing Readiness Support transition from development to engineering runs and GMP manufacturing. Ensure manufacturing plans support regulatory submissions and clinical timelines. Cross‑Functional and Multi‑Program Leadership 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. Team Building and Leadership 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. Qualifications 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. What Success Looks Like (first 3–6 months) Establish governance and oversight processes for existing CDMO partners. Deliver an integrated external CMC timeline and budget aligned with program development goals. Identify operational risks within the external manufacturing network and implement mitigation plans. Ensure CDMOs are positioned to support upcoming engineering runs and GMP manufacturing activities. Build and scale their team per business needs and associated budget. Working Conditions / Physical Requirements (as applicable) Up to 20% travel to CDMO partners or manufacturing sites. Combination office and occasional manufacturing‑site visits depending on project needs. Compensation and Benefits The expected salary range for this role based on the primary location for this position in California is $270 - $315k per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job‑related factors permitted by law. Equal Employment Opportunity (EEO): Azalea is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, ancestry, age, disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable law. Reasonable Accommodation: We will provide reasonable accommodation to qualified individuals with disabilities and to individuals with sincerely held religious beliefs, consistent with applicable law. Applicant Privacy: Azalea collects and uses applicant personal information for recruiting and employment purposes. If applicable, Azalea will provide a California applicant privacy notice describing categories of information collected, purposes, retention, and rights under the California Consumer Privacy Act (CCPA/CPRA). Job Description Disclaimer: This job description may change at any time based on business needs. It is not a contract and does not create a promise of employment for any particular duration. Notice to Recruiters/Staffing Agencies: Recruiters and staffing agencies should not contact Azalea Therapeutics through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with Azalea prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with Azalea, and Azalea will not be responsible for any purported fees. Information on Fraudulent Job Offers: Azalea is aware that some job seekers have received false employment offers or recruitment emails from individuals or organizations posing as Azalea. The individuals or organizations sending these false employment offers may send requests seeking to gain personal information, items of value or monetary funds under the premise that doing so is required to further the recruitment process. Azalea never requests passport details, financial information, items of value or money from job seekers for any reason as part of the recruitment process . Individuals who receive an offer of employment from Azalea are always required to go through a formal recruitment process, which includes an interview with a member of Azalea’s Human Resources recruitment team and the hiring manager. 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The Internet Crimes Complaint Center is an FBI entity that aggregates criminal events in order to analyze and prosecute numerous related scams. #J-18808-Ljbffr Valid8 Financial, Inc.