6 дней назад
Scientist, Drug Product Analytical (LNP)
130 000 - 170 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Scientist, Drug Product Analytical (LNP) (mRNA and lipid nanoparticle analytics): Developing analytical methods to characterize RNA drug substances, LNP drug products, and LNP conjugates with an accent on purity, integrity, identity, lipid content, and particle characterization. Focus on method qualification, validation, tech transfer, stability studies, and supporting RNA/LNP development from discovery through GLP/GMP stages.
Location: South San Francisco, United States
Salary: $130,000–$170,000 per year
Company
is a biotechnology company developing medicines for age-related diseases by reprogramming the epigenome and restoring regenerative potential in aged and diseased cells.
What you will do
- Design and execute analytical methods to assess the identity, integrity, and purity of RNA drug substances, LNP drug products, and LNP conjugates.
- Analyze mRNA integrity, identity, lipid content, lipid identity, particle size, polydispersity, and particle distribution.
- Support RNA and LNP drug development from early discovery through GLP/GMP stages.
- Provide technical expertise to CRO and CDMO partners during method development, validation, tech transfer, and PK/PD assay development.
- Interpret analytical assay data, prepare data packages, and author technical reports, SOPs, and validation protocols for regulatory filings.
Requirements
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field, plus 1–3 years of industry experience.
- Direct experience with mRNA-LNP delivery systems.
- Expertise in IP-RP LC-UV/FLR for RNA purity, integrity, and content analysis.
- Expertise in LC-CAD method development for lipid purity, content, and lipid adduct analysis.
- Experience with capillary electrophoresis for RNA integrity analysis in drug substances and LNP drug products.
- Expertise in DLS, MALS, or Cryo-TEM for particle characterization.
Nice to have
- Knowledge of ICH Q2 (R1) and Q14 guidelines for method qualification and validation.
- Experience transferring analytical methods to Contract Development and Manufacturing Organizations.
- Experience with DoE, data visualization, and statistical analysis using JMP, Python, or R.
Culture & Benefits
- Health, dental, and vision insurance.
- 401(k) with company match.
- Paid parental leave.
- 20 days of paid time off per year plus holidays.
- Meals and snacks provided on-site.
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