Scientist, Viral Vector Process Development, Upstream

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 thataccelerates AstraZenecas emerging Cell Therapy modalities portfolio. You will designexecute and optimize upstream Lentiviral Vector (LVV) processes with a primary focus onsuspension bioreactor platforms at clinical and commercial scales. You will contributehands-on to experimental design process characterization and scale-up/tech transferactivities from research through IND enabling partnering closely with Research Analytical
Development CMC Regulatory Manufacturing Quality and external CDMOs. Thisposition is based in Gaithersburg MD.

Key Responsibilities:

• Upstream Process Development: Plan and perform experiments to develop andoptimize LVV upstream processes for suspension cell culture (transient or stableproducer 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 pilotand clinical scales; develop and use scale-down models for characterization andcomparability.

• Experimental Design & Data Analysis: Design DOE studies identify CPPs/CMAsanalyze data and propose control strategies; document results in protocols andreports; maintain fit for purpose knowledge records.

• Tech Transfer & GMP Interface: Prepare technical transfer packages and supporttransfers to internal GMP sites and CDMOs; align process documentation withcGMP principles for late-stage readiness.

• Cross-Functional Collaboration: Work closely with Analytical Development onassay readiness and in process testing; partner with Manufacturing Supply andQuality 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 cycletime right first time) and recommend improvements.

Qualifications:

• Education: MS/BS in Engineering Biotechnology or related field.

• Years ofexperiences in industry: MS with 14 years; or BS with 36 years.

• Experience: Handson experience developing suspension-based LVV upstreamprocesses; familiarity with clinical scale considerations and technology transfer.

• Technical Skills: Proficiency in suspension cell culture transfection/infectionstrategies media/feed optimization single use rocking-platform and stirred-tankbioreactors and upstreamharvest interfaces;

• Communication & Teamwork: Strong written and verbal communication skills;ability to work effectively in cross functional matrixed teams; demonstratedproblem solving and troubleshooting capabilities.

• Preferred Qualifications:

• Demonstrated success scaling suspension LVV processes to pilot/clinical scalesand sustaining performance via monitoring and continuous improvement.

• Experience linking upstream parameters to analytical outcomes (titerinfectivity/potency residuals/impurities) to guide process decisions.

• Contributions to regulatory filings (data tables process descriptions) andparticipation in tech transfer to CDMOs or internal GMP sites.

• Tools & Automation: Experience with single use systems process automation/PATand 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 $92252.00 - $138378.00. Our positions offer eligibility for various incentivesan 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 Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.