Senior Scientist, Viral Vector Process Development, Upstream

AstraZeneca is looking for a highly motivated and experiencedSenior Scientist Viral Vector Process Development (Upstream). The candidate will play a critical role in building and leading a high-performingteamthat accelerates AstraZenecas emerging Cell Therapy modalities portfolio. Youwill design execute andoptimizeupstream Lentiviral Vector (LVV) processes with a primary focus onsuspensionbioreactor platformsatclinical and commercial scales. You will contribute hands-on to experimental design process characterization and scale-up/tech transfer activities from research throughINDenabling 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 andoptimizeLVV upstream processes forsuspensioncell culture(transient orstableproducer cell systems) targeting improvements intiter 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 usescale-down modelsfor characterization and comparability.

• Experimental Design & Data Analysis: Design DOE studiesidentifyCPPs/CMAs analyze data and propose control strategies; document results in protocols and reports; maintainfit forpurposeknowledge 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 withcGMPprinciples for late-stage readiness.

• Cross-Functional Collaboration: Work closely with Analytical Development on assay readiness andin processtesting; 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 timeright first time) and recommend improvements.

Qualifications

• Education: PhD in Biology Virology Biotechnology or related field with 25 years of relevant industry experience; or MS with 58 years; or BS with 810 years.Titlewill becommensuratewith qualifications and experience.

• Experience: Handsonexperiencedevelopingsuspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations process characterization and technology transfer.

• Technical Skills:Proficiencyin suspension cell culture transfection/infection strategies media/feed optimizationsingleuserocking-platform andstirred-tank bioreactors and upstreamharvest interfaces; working knowledge ofstatistical DOEand data analytics tools.

• GMP Readiness: Experience supportingcGMPinterfaces (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 incrossfunctional matrixed teams; demonstratedproblemsolvingand troubleshooting capability.

• Tools & Automation: Experience withsingleusesystems process automation/PAT and digital lab systems (ELN/LIMS) preferred.

Preferred Qualifications

• Demonstrated success scalingsuspension LVV processesto 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.

The annual base pay for this position ranges from $108473.60 - $162710.40. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

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.

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