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AstraZeneca · 23 hours ago

Senior Process Engineer, Viral Vector, Upstream

Gaithersburg, MD

Full-time

Onsite

Mid, Senior Level

$97K/yr - $146K/yr

2+ years exp

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, focusing on designing, executing, and optimizing upstream processes.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

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 fitforpurpose knowledge records

Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive troubleshooting, root cause analysis, and corrective actions

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 inprocess 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, rightfirsttime) and recommend improvements

Qualification

Suspension cell cultureBioreactor operationsProcess characterizationCGMP complianceStatistical DOEData analytics toolsProcess automationCommunication skillsTeamworkProblem-solving

Required

Education: PhD in Chemical/Biomedical Engineering, Biotechnology, or related field with 2–5 years of relevant industry experience; or MS with 5–8 years; or BS with 8–10 years. Title will be commensurate with qualifications and experience

Experience: Hands-on 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, single-use 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 cross-functional, matrixed teams; demonstrated problem-solving and troubleshooting capability

Tools & Automation: Experience with single-use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred

Preferred

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

Benefits

Short-term incentive bonus opportunity

Eligibility to participate in our equity-based long-term incentive program

Qualified retirement program [401(k) plan]

Paid vacation and holidays

Paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (2)

2020 (11)