Director, Viral Vector Process Development, Downstream
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Job Location:
Gaithersburg, MD - USA
Monthly Salary:
$ 172672 - 259008
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
AstraZeneca is looking for a highly motivatedexperiencedand strategicDirector 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 AstraZenecasProcess 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 developscalable cost-effective GMP compliance LVV manufacturing processes to support a variety of ex vivo and in vivo cell therapy programs
Buildleadand 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
Guidethe execution ofviralvector process development characterization and phase-appropriate validation activities as well as tech transfer of processes to manufacturing facilities
Providetechnicalexpertiseand 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 technicaldocuments and relevant process/regulatory documentsengageregulatory authoritiesas needed
Buildandmaintaina 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:
Demonstratedextensive experience in Lentiviral Vector (preferred) other viralvectorsor biologics downstream process development
SME in clarification chromatography UF/DF TFF sterile filtration formulation etc.
Experiencescaling 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 DOEQbD FMEA process justification
Knowledge of GMP and Quality systems requirementsFDAand 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-2025Closing Date
27-Nov-2025Our 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
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
