Senior Scientist, Viral Vector Process Development, Upstream Full-time

Senior Scientist, Viral Vector Process Development (Upstream)

AstraZeneca is looking for a highly motivated and experienced Senior Scientist, Viral Vector Process Development (Upstream). 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 upstream Lentiviral Vector (LVV) processes with a primary focus on suspension bioreactor platforms at 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

• Upstream Process Development: Plan and perform experiments to develop and optimize LVV upstream processes for suspension cell culture (transient or stable producer cell systems), targeting improvements in titer, quality, robustness, and cost.
• Bioreactor Operations & Scale Translation: Execute unit operations across seed, production, and harvest interfaces; support scale-up strategies from bench to pilot and clinical scales; develop and use scale-down models for characterization and comparability.
• Experimental Design & Data Analysis: Design DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain fit for purpose knowledge records.
• Process Characterization & Control: Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive troubleshooting, root cause analysis, and corrective actions.
• Tech Transfer & GMP Interface: Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation with cGMP principles for late-stage readiness.
• Cross-Functional Collaboration: Work closely with Analytical Development on assay readiness and in process testing; partner with Manufacturing, Supply, and Quality to ensure operational feasibility and compliance.
• Operational Excellence: Apply Lean practices and digital tools for scheduling, data integrity, and reproducibility; track KPIs (titer, infectivity, impurity profiles, cycle time, right first time) and recommend improvements.

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 experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer.
• Technical Skills: Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, single use rocking-platform and stirred-tank bioreactors, and upstream–harvest interfaces; working knowledge of statistical DOE and data analytics tools.
• GMP Readiness: Experience supporting cGMP interfaces (documentation, change control, sampling plans) and contributing to CMC sections or technical responses is a plus.
• Communication & Teamwork: Strong written and verbal communication skills; ability to work effectively in cross functional, matrixed teams; demonstrated problem solving and troubleshooting capability.
• Tools & Automation: Experience with single use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.

Preferred Qualifications

• Demonstrated success scaling suspension LVV processes to pilot/clinical scales and sustaining performance via monitoring and continuous improvement.
• Experience linking upstream parameters to analytical outcomes (titer, infectivity/potency, residuals/impurities) to guide process decisions.
• Contributions to regulatory filings (data tables, process descriptions) and participation in tech transfer to CDMOs or internal GMP sites.
• Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs.

At AstraZeneca, we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly changing markets by continuously seeking better ways to deliver medicines to patients. Our team is diverse and connected globally, working together to push the boundaries of supply chain excellence. With a focus on sustainability and a commitment to doing things the right way, we offer opportunities for growth and development in a supportive environment.

Join us in making a difference—apply today!