Drug Product Development Scientist - Viral Vector

AstraZeneca is looking for a highly motivated and experienced Drug Product Scientist for viral vector process development. The candidate will play a critical role in forming a high-performing team that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. You will design, execute, and optimize scalable Lentiviral Vector (LVV) drug product formulation, fill & finish processes with a primary focus on clinical and commercial scales. You will contribute hands-on to experimental design, execution, process characterization, and scale-up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs. This position is based in Gaithersburg, MD.   

Key Responsibilities  

• Formulation Development: Plan and perform experiments to develop new platform LVV formulations for ex vivo and in vivo applications.  

• Fill and finish Development: Design, test, and support drug product fill and finish activities at pilot scale and clinical scale, including particle characterization, drug product filling, containers studies, stability, labeling and packaging etc.    

• Tech Transfer Support: Develop representative DP scale-down models; support tech transfer to clinical, and commercial GMP sites.  

• Process Characterization: Design and execute studies (including DOE) to support establish design space, conduct troubleshooting and root cause analysis, and recommend corrective actions.  

• Novel Technologies & Continuous Improvement: Evaluate and implement next-generation drug product and formulation technologies to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives.  

• Documentation & Compliance: Author high-quality protocols, reports, batch records, and development summaries; support drafting of CMC content for regulatory submissions (e.g., IND) and align practices with cGMP and Quality systems expectations.  

• Cross-Functional Collaboration: Partner with upstream PD and Analytical Development to link process parameters with product quality attributes (e.g., titer, infectivity/potency, residuals/impurities); collaborate with Manufacturing and Quality on operational feasibility and compliance.  

Qualifications  

• Education: M.S. with 2+ years; OR B.S. with 4+ years of hands‑on industry experience. 

• Experience: Hands-on drug product development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale fill and finish.  

• Technical Expertise: Practical proficiency in UFDF, formulation development, particle characterization, manual& automated drug product filling, container closure, and stability studies.  

• GMP & Regulatory: Understanding of cGMP and Quality systems; familiarity with FDA/EMA guidance releva