Director, Viral Vector Process Development, Downstream

AstraZeneca is looking for a highly motivated,experiencedand strategic Director to lead our Viral Vector Process Development, Downstreamteam. The successful candidate will be an integral leader of process development for the viral vector programs at AstraZeneca’sProcess 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 LVVdownstream operations, with a proven track record of advancing candidates from research through IND-enabling studies as well as commercialization.This rolewilloperatestrategically in a highly collaborative environment, partnering closely with internal and externalshareholders.

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 ofviralvector process development, characterization, and phase-appropriate validation activities, as well as tech transfer of processes to manufacturing facilities

• Provide technicalexpertiseand strategic leadership within project teams and in a matrix environment with a focus onviral 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,engageregulatory authoritiesas needed

• Build andmaintaina collaborative culture with key internal shareholdersand 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 becommensuratewith qualification and experience 

Preferred Qualifications:

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

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

• Experience scaling Lentiviral Vector (preferred), other viralvectorsor biologics processesfrom pre-clinicalto 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/implementnext-generation process technologies

• Strong skills in statistical data analysis, familiarity with DOE,QbD, FMEA, process justification

• Knowledge of GMP and Quality systems requirements,FDAand 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.