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.

• 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.

• Education: PhD in Biochemical/Chemical Engineering, Biotechnology, or related field with 2–5 years of relevant industry experience; or MS with 5–8 years; or BS with 8–10 years. Cell and gene therapy experience preferred. Title will be commensurate with qualifications and 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 analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification.
• GMP & Regulatory: Understanding of cGMP and Quality systems; familiarity with FDA/EMA guidance relevant to gene and cell therapy; experience contributing to CMC sections of regulatory filings is a plus.
• Communication &
  
  Collaboration:
  
  Strong written and verbal communication; ability to work effectively in cross‑functional, matrixed teams; demonstrated problem‑solving and troubleshooting skills.

• Experience scaling LVV or other viral vector/biologic purification processes from preclinical to clinical/commercial‑relevant equipment and consumables.
• Experience supporting tech transfer and implementation at internal sites and CDMOs.
• Exposure to PAT/digital tools for process monitoring and data integrity; experience with knowledge management systems.
• De…