Alexion Pharmaceuticals, Inc. · 14 hours ago
Senior Process Engineer, Viral Vector, Upstream
Gaithersburg, Maryland, United States of America
Full-time
Onsite
Mid, Senior Level
$97K/yr - $146K/yr
2+ years expAstraZeneca 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 Lentiviral Vector processes.
BiotechnologyHealth CareMedicalTherapeutics
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
Required
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
Handson experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer
Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, singleuse rocking-platform and stirred-tank bioreactors, and upstream–harvest interfaces; working knowledge of statistical DOE and data analytics tools
Experience supporting cGMP interfaces (documentation, change control, sampling plans) and contributing to CMC sections or technical responses is a plus
Strong written and verbal communication skills; ability to work effectively in crossfunctional, matrixed teams; demonstrated problemsolving and troubleshooting capability
Experience with singleuse 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
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
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
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Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
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2025-12-20
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