Alexion Pharmaceuticals, Inc. · 11 hours ago
Senior Process Engineer, Viral Vector, Downstream
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, Viral Vector, for downstream 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 scalable Lentiviral Vector downstream purification processes.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Plan and perform experiments to develop scalable, cost-effective LVV purification processes for ex vivo and in vivo applications, targeting yield, purity, potency, and consistency
Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill-related steps; define phase-appropriate in-process controls and operating ranges
Design and analyze studies (including DOE) to identify CPPs/CMAs, establish design space, and justify control strategies; trend performance, conduct troubleshooting and root cause analysis, and recommend corrective actions
Develop representative scale-down models; support scale-up to pilot, clinical, and commercial-relevant equipment; prepare technical transfer documents and assist transfers to internal GMP sites and CDMOs
Evaluate and implement next-generation purification technologies and consumables to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives
Author high-quality protocols, reports, batch records, and development summaries; support drafting of CMC content for regulatory submissions (e.g., IND) and align practices with cGMP and Quality systems expectations
Partner with upstream PD and Analytical Development to link process parameters with product quality attributes (e.g., titer, infectivity/potency, residuals/impurities); collaborate with Manufacturing and Quality on operational feasibility and compliance
Qualification
Required
PhD in Biochemical/Chemical 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
Hands-on downstream process development for LVV (preferred) or other viral vectors/biologics
Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation
Understanding of viral vector-specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them
Working knowledge of statistical analysis and DOE
Familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification
Understanding of cGMP and Quality systems
Familiarity with FDA/EMA guidance relevant to gene and cell therapy
Strong written and verbal communication
Ability to work effectively in cross-functional, matrixed teams
Demonstrated problem-solving and troubleshooting skills
Preferred
Experience scaling LVV or other viral vector/biologic purification processes from preclinical to clinical/commercial-relevant equipment and consumables
Experience supporting tech transfer and implementation at internal sites and CDMOs
Exposure to PAT/digital tools for process monitoring and data integrity
Experience with knowledge management systems
Demonstrated innovation in evaluating/implementing next-generation purification technologies
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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Distribution of Different Job Fields Receiving Sponsorship
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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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