AstraZeneca is looking for a highly motivated and experienced Senior Process Engineer for Viral Vector Upstream 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 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: Develop 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 solving, 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: Handson 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, singleuse 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 crossfunctional, matrixed teams; 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 evolving markets by continuously seeking innovative 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 dedication 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!
The annual base pay (or hourly rate of compensation) for this position ranges from $112,304.00 - 168,456.00. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted16-Sep-2026
Closing Date15-Sep-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.
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