AstraZeneca is looking for a highly motivated experienced and strategicDirector 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 AstraZenecas 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. Th is role will operate strategically in a highly collaborative environment partnering closely with internal and external shareholders .
Responsibilities :
Design and developscalable 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
C ollaborate 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
Guidethe execution of v iral v ector process development characterization and phase-appropriate validation activities as well as tech transfer of processes to manufacturing facilities
Providetechnical expertise and strategic leadership within project teams and in a matrix environment with a focus on viral vector down stream process development
Lead initiatives to evaluate and implement novel technologies to improve purification efficiency and product quality
Lead efforts to author technicaldocuments and relevant process / regulatory documents engag e regulatory authorities as needed
Buildand maintain a collaborative culture with key internal shareholder s 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 :
Demonstratedextensive experience in Lentiviral Vector (preferred) other viral vectors or biologics downstream process development
SME in clarification chromatography UF / DF TFF sterile filtration formulation etc.
Experiencescaling 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 $ 172672.00 - $259008.00 . Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and 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.
Date Posted
10-Nov-2025
Closing Date
27-Nov-2025
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
Required Experience :
Director
Key Skills
Fundraising,Management Experience,Biotechnology,Clinical Development,Clinical Trials,Research & Development,Training & Development,Grant Writing,Economic Development,Leadership Experience,Public Speaking,Product Development
Employment Type : Full-Time
Experience : years
Vacancy : 1
Monthly Salary Salary : 172672 - 259008
Director Development • Gaithersburg, Maryland, USA