10 дней назад
Scientist II R&D (mRNA/LNP Analytics)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Scientist II R&D (mRNA/LNP Analytics): Developing and executing analytical methods and services for mRNA, sgRNA, and lipid nanoparticles with an accent on bio-physical and chemical characterization, assay optimization, and regulatory support. Focus on establishing laboratory processes, analyzing complex data, leading client-facing projects, and presenting technical findings to clients and senior management.
Location: Fargo, North Dakota, United States; on-site
Company
Aldevron is a operating company providing CDMO services that support the development of genomic medicines and life-science therapies.
What you will do
- Design and execute analytical services and technologies for mRNA, sgRNA, and lipid nanoparticles.
- Lead experiments involving biophysical and chemical data analysis, assay optimization, and analytical method development.
- Establish laboratory processes, including laboratory preparation, equipment installation and qualification, and SOP development.
- Review analytical documents supporting client regulatory filings and prepare detailed project reports.
- Present findings and recommendations to clients and senior management while coordinating knowledge transfer between clients and analytical teams.
- Manage multiple projects through prioritization, planning, scheduling, and deadline tracking.
Requirements
- PhD in biotechnology, biochemistry, or a related discipline with at least 1 year of industry experience; or MS with at least 2 years; or BS with at least 5 years of related industry experience.
- Experience with biologics development and optimization, assay optimization, experimental design, data analysis, and presentation of concepts.
- Knowledge of compendial and non-compendial regulatory guidelines for phase-appropriate analytical method development and validation.
- Bioanalytical method development experience, including chromatographic or electrophoretic separation methods and biophysical or chemical characterization of biologics.
- Strong communication and organizational skills, including presentation development, findings synthesis, and client-facing troubleshooting.
- On-site work in Fargo, North Dakota, United States is required.
Nice to have
- CDMO experience.
- Analytical method qualification or comparability experience.
- Experience using HPLC for analytical methods.
- Experience discussing, defending, or authoring analytical topics for auditors or regulators.
Culture & Benefits
- Mission-driven work supporting life sciences, diagnostics, biotechnology, and genomic medicine.
- Collaborative environment focused on scientific innovation, quality, and continuous improvement.
- Comprehensive benefits, including health care programs and paid time off.
- Limited travel may be required, typically 2–4 weeks per year.
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