Director, Viral Vector Process Development, Downstream

Role Summary

AstraZeneca is looking for a highly motivated, experienced and strategic Director to lead our Viral Vector Process Development, Downstream team. The successful candidate will be an integral leader of process development for the viral vector programs within PSAT/CTDO, focusing on downstream process development and scale-up of Lentiviral Vector manufacturing. The role requires deep technical expertise and leadership in LVV downstream operations, with a track record of advancing candidates from research through IND-enabling studies and commercialization. The position involves strategic collaboration with internal and external stakeholders.

Responsibilities

• Design and develop scalable, cost-effective, GMP-compliant LVV manufacturing processes to support ex vivo and in vivo cell therapy programs
• Build, lead, and develop a high-performing Viral Vector Process Development, Downstream group
• Collaborate cross-functionally within Viral Vector and New Modality Development and engage with internal stakeholders and external partners
• Guide the execution of viral vector process development, characterization, and phase-appropriate validation activities, and tech transfer of processes to manufacturing facilities
• Provide technical expertise and strategic leadership within project teams in a matrix environment with a focus on viral vector downstream process development
• Lead initiatives to evaluate and implement novel technologies to improve purification efficiency and product quality
• Lead efforts to author technical documents and relevant process/regulatory documents, and engage regulatory authorities as needed
• Build and maintain a collaborative culture with key internal shareholders and external partners

Qualifications

• PhD in relevant Engineering or Science majors with 8+ years of related industry experience, or MS with 12+ years of related industry experience (cell and gene therapy experience preferred)
• Title will be commensurate with qualification and experience

Preferred Qualifications

• Extensive experience in Lentiviral Vector (preferred) or other viral vectors or biologics downstream process development
• Subject Matter Expert in clarification, chromatography, UF/DF, TFF, sterile filtration, formulation, etc.
• Experience scaling Lentiviral Vector or other viral vector/biologic processes from pre-clinical to clinical/commercial manufacturing scales
• Experience managing scale-up, tech-transfer, and implementation of purification processes with internal and external manufacturing partners
• Experience authoring technical documents and contributing to drafting of CMC sections of regulatory submissions (IND, BLA)
• Ability to innovate solutions for current technical challenges and evaluate/implement next-generation process technologies
• Strong skills in statistical data analysis, familiarity with DOE, QbD, FMEA, process justification
• Knowledge of GMP and Quality systems requirements, FDA and EMA guidance relevant to gene and cell therapy