Director, Viral Vector Process Development, Downstream

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 at AstraZeneca’s Process Science and Technology (PSAT), Cell Therapy Development and Operation (CTDO) organization, with a dedicated focus on downstream process development and scale-up of Lentiviral Vector (LVV) manufacturing processes. The successful candidate will bring deep technical expertise and leadership in LVV downstream operations, with a proven track record of advancing candidates from research through IND-enabling studies as well as commercialization. This role will operate strategically in a highly collaborative environment, partnering closely with internal and external shareholders. 

 
Responsibilities: 

• Design and develop scalable, cost-effective, GMP compliance LVV manufacturing processes to support a variety of 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 organization as well as being a key player in interactions with internal stakeholders and external partners 

• Guide the execution of viral vector process development, characterization, and phase-appropriate validation activities, as well as tech transfer of processes to manufacturing facilities 

• Provide technical expertise and strategic leadership within project teams and 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, engage regulatory authorities as needed 

• Build and maintain a collaborative culture with key internal shareholders and external partners  

Education and Experience: 

• PhD in relevant Engineering or Science majors and 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: 

• Demonstrated extensive experience in Lentiviral Vector (preferred), other viral vectors or biologics downstream process development  

• SME in clarification, chromatography, UF/DF, TFF, sterile filtration, formulation, etc. 

• Experience scaling Lentiviral Vector (preferred), other viral vectors or biologics processes from pre-clinical to clinical/commercial manufacturing scales  

• Experience managing scale-up, tech-transfer, and implementation of purification processes at internal and external manufacturing partners 

• Experience authoring technical documents and supporting drafting of CMC sections of regulatory submissions (IND, BLA) 

• Innovate solutions to address 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 

The annual base pay for this position ranges from $172,672.00 - $259,008.00. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.