Alexion Pharmaceuticals, Inc. · 1 day ago
Process Engineer, Upstream Process Characterization & Commercialization
Gaithersburg, Maryland, United States of America
Full-time
Onsite
Mid, Senior Level
$76K/yr - $114K/yr
1+ years expAlexion Pharmaceuticals, Inc. is seeking a highly motivated Engineer to support upstream process characterization and commercialization activities for viral vector programs. The role involves contributing to late-stage development, process characterization, and technology transfer to manufacturing sites, focusing specifically on upstream unit operations.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Design, execute, and support upstream process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments)
Develop and execute characterization strategies to define CPP–CQA linkages for upstream unit operations
Perform data analysis, technical report authorship, and presentation of study outcomes to cross‑functional teams and governance forums
Support development and refinement of control strategies for upstream processes, including raw materials, transfection reagents, cell banks, and process parameters
Conduct batch record review, deviation assessment, and data trending to ensure robustness of upstream manufacturing processes
Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding
Contribute to PPQ planning, readiness, execution, and documentation for upstream processes
Support technology transfer of upstream processes to internal manufacturing sites and CDMOs, including fit‑for‑purpose assessments and scale translation
Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required)
Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms
Contribute to authoring and review of CMC documentation, including upstream process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements
Support preparation of BLA/MAA submissions and responses to regulatory questions related to upstream manufacturing
Work closely with downstream, analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment
Represent upstream characterization activities in technical meetings, reviews, and governance discussions
Support lifecycle management, post‑approval changes, and continuous improvement initiatives for upstream processes
Qualification
Required
Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience
Hands‑on experience with upstream viral vector manufacturing, including transient transfection‑based processes
Experience with shake flask, bench‑scale, pilot‑scale, and commercial bioreactor systems; experience with Amber systems strongly preferred
Experience with late‑stage development, process characterization, and PPQ principles for upstream processes
Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation
Experience working in GMP environments, including batch record execution or review, deviations, and investigations
Strong technical writing, data analysis, and problem‑solving skills
Preferred
Experience supporting late‑stage viral vector programs (lentiviral, AAV, adenoviral, VLPs)
Experience designing and executing DOE and multivariate data analysis for upstream processes
Experience contributing to BLA/MAA submissions or regulatory interactions
Knowledge of control strategy development and risk assessment tools (e.g., FMEA)
Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development
Benefits
Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
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
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
Represents job field similar to this job
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
bloomberglaw.com
2025-12-20
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