The candidate will play a critical role within 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.
- 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: MS/BS in Engineering, Biotechnology, or related field.
- Years of experiences in industry: MS with 1-4 years; or BS with 3-6 years.
- Experience: Handson experience developing suspension-based LVV upstream processes; familiarity with clinical scale considerations, 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;
- Communication & Teamwork: Strong written and verbal communication skills; ability to work effectively in cross functional, matrixed teams; demonstrated problem solving and troubleshooting capabilities.
- 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.
- Tools & Automation: Experience with single use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.
- Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs
The annual base pay for this position ranges from $92,252.00 - $138,378.00. 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 Posted06-Jul-2026
Closing Date23-Jul-2026
