Alexion Pharmaceuticals, Inc. · 16 hours ago
Associate Principal Scientist, Vector Engineering and Cell Line Development
Gaithersburg, Maryland, United States of America
Full-time
Onsite
Senior Level, Lead/Staff
$135K/yr - $202K/yr
5+ years expAlexion Pharmaceuticals, Inc. is seeking an Associate Principal Scientist to drive vector engineering and cell line development for lentiviral vector manufacturing. The role involves designing and optimizing plasmids to improve product quality and compliance while collaborating with various departments to translate designs into scalable processes.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Design, build, and optimize plasmids and expression cassettes (promoters, enhancers, codon usage, ITR/LTR elements, insulators, ORF engineering) to increase vector productivity and quality while reducing recombination risks and plasmid burden
Engineer vectors with built-in safety controls (split genomes, self-inactivating elements), reduce RCL risk, and minimize integration-competent vector species; align designs with global regulatory expectations and internal quality standards
Evaluate and implement cell substrates for viral vector production, including transient transfection systems, stable packaging lines, and producer cell lines; compare productivity, product quality, cost, and scalability
Generate and characterize stable clones (vector integration, copy number, expression stability, growth/production kinetics); implement selection strategies and gene/vector architectures to enhance stability and yield
Collaborate with internal and external partners, contribute to the development of inducible/regulated producer cell lines; assess leakiness, cytotoxicity, and long-term stability; design induction strategies compatible with GMP manufacturing
Define and execute characterization plans linking design choices to critical quality attributes (genome integrity, potency, residuals, empty/full ratios); collaborate with Analytical Development on assays (qPCR/ddPCR, NGS, ELISA, infectivity/potency)
Prepare technical reports, clone/construct histories, sequence maps, and development summaries; author transfer packages and support implementation at pilot and GMP sites in alignment with cGMP and data integrity expectations
Working with upstream (bioreactor), downstream (purification), and analytical teams to translate designs into scalable, phase-appropriate processes
Evaluate next-generation vector backbones, promoters, regulatory elements, and cell engineering tools; assess new cell hosts and media/feed platforms for improved manufacturability
Qualification
Required
PhD in Molecular Biology, Cell Biology, Bioengineering, Virology, or related field with 5–8 years of industry experience or MS with 10+ years. Title will be commensurate with qualifications and experience
Hands-on experience in plasmid/vector engineering and mammalian cell line development for viral vectors in development or manufacturing contexts
Plasmid construct design, cloning, sequence verification, and optimization for expression and manufacturability
Mammalian cell culture in adherent and suspension; development of stable packaging and/or producer lines, including vector integration strategies and clone screening
Transient transfection optimization at bench and pilot scales; familiarity with single-use bioreactors and scalable transfection workflows
Understanding of vector biology and biosafety (e.g., RCL/RCA risk, helper functions, split genomes, SIN LTRs)
Proficiency with qPCR/ddPCR, sequencing, and relevant product analytics; working knowledge of DOE and statistical analysis
Familiarity with cGMP expectations for starting materials (plasmids, cell banks) and phase-appropriate documentation; experience contributing to CMC sections is a plus
Strong written and verbal communication; ability to work cross-functionally and translate designs into process requirements
Preferred
Experience creating inducible producer cell lines and assessing stability across passages and induction cycles
Background in genome engineering (CRISPR/Cas, recombinase-mediated cassette exchange, safe-harbor integration, landing pad strategies)
Experience with high-throughput clone screening, automation, and electronic lab systems (ELN/LIMS)
Demonstrated linkage of vector/cell design changes to manufacturing KPIs (titer, potency, impurity profile, empty/full, RCL/RCA)
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
guarantee sponsorship for this specific role. Below presents additional info for your
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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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