Senior Process Engineer, Viral Vector, Downstream

AstraZeneca is looking for a highly motivated and experienced Senior Process Engineer, Viral Vector, for downstream process development. The candidate will play a critical role in building and leading a high-performing team that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio. You will design, execute, and optimize scalable Lentiviral Vector (LVV) downstream purification processes with a primary focus on clinical and commercial scales. You will contribute hands-on to experimental design, 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 

• Downstream Process Development: Plan and perform experiments to develop scalable, cost-effective LVV purification processes for ex vivo and in vivo applications, targeting yield, purity, potency, and consistency. 

• Unit Operations Execution: Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill-related steps; define phase-appropriate in-process controls and operating ranges. 

• Process Characterization & Data Analysis: Design and analyze studies (including DOE) to identify CPPs/CMAs, establish design space, and justify control strategies; trend performance, conduct troubleshooting and root cause analysis, and recommend corrective actions. 

• Scale-Up, Scale-Down & Tech Transfer Support: Develop representative scale-down models; support scale-up to pilot, clinical, and commercial-relevant equipment; prepare technical transfer documents and assist transfers to internal GMP sites and CDMOs. 

• Novel Technologies & Continuous Improvement: Evaluate and implement next-generation purification technologies and consumables 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: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience.

• Experience: Hands-on downstream process development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer. 

• Technical Expertise: Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding of viral vector-specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them. 

• Data & Risk Tools: Working knowledge of statistical a