Scientist, Viral Vector Process Development, Upstream

AstraZeneca • Gaithersburg, MD

5d • Onsite

About The Position

AstraZeneca is looking for a highly motivated Scientist, Viral Vector Process Development (Upstream). 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.

Requirements

• MS/BS in Engineering, Biotechnology, or related field.
• MS with 1–4 years; or BS with 3–6 years of industry experience.
• Handson experience developing suspension-based LVV upstream processes; familiarity with clinical scale considerations, and technology transfer.
• Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, single use rocking-platform and stirred-tank bioreactors, and upstream–harvest interfaces.
• Strong written and verbal communication skills.
• Ability to work effectively in cross functional, matrixed teams.
• Demonstrated problem solving and troubleshooting capabilities.

Nice To Haves

• 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 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.

Responsibilities

• 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.
• 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.
• Design DOE studies, identify CPPs/CMAs, analyze data and propose control strategies; document results in protocols and reports; maintain fit for purpose knowledge records.
• Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation with cGMP principles for late-stage readiness.
• Work closely with Analytical Development on assay readiness and in process testing; partner with Manufacturing, Supply, and Quality to ensure operational feasibility and compliance.
• 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.

Benefits

• Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles
• Qualified retirement programs
• Paid time off (i.e., vacation, holiday, and leaves)
• Health, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree