NewLimit
Scientist, Drug Product Analytical
South San Francisco
Sponsorship not specified$130k-$170kDetected 70 days ago
PythonMachine LearningData VisualizationStatisticsGMPBioinformatics
About the role
- Interpret data from various analytical assays, reports and prepare data packages
Responsibilities
- Design and execute analytical methods to assess the identity, integrity and purity of RNA drug substances and LNP drug products and LNP-conjugates
- Perform deep-dive analysis into mRNA integrity, identity, lipid content and identity analysis to support drug product stability studies
- Work closely with the cross-functional teams to support RNA and LNP analysis for drug development from early discovery to GLP/GMP stages.
- Act as a technical expert for our CRO/CDMO partners on drug substance and drug product analytical method development, validation phases and PK/PD assay developments
- Author high-quality technical reports, SOPs, and validation protocols to support regulatory filings
- Capillary Electrophoresis (CE): Experience developing RNA integrity analysis in both Drug Substance (DS) and LNP Drug Product (DP)
Requirements
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 1-3 years of industry experience with direct experience working with mRNA-LNP delivery systems
- IP-RP LC-UV/FLR: Expertise in Ion-Pair Reversed-Phase Chromatography for determining RNA purity, integrity and content
- LC-CAD: Expertise in method development for lipid purity, content and lipid adducts analysis.
- DLS/MALS/Cryo-TEM: Expertise in particle size, polydispersity and particle distribution analysis
Nice to have
- Understanding of ICH guidelines regarding method qualification and validation ICH Q2 (R1) and Q14
- Proven success in tech-transferring analytical methods to Contract Development and Manufacturing Organizations.
- DoE, data visualization and statistical analysis (JMP, Python, R)
Compensation
- $130,000 to $170,000.
- Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience.
- Learn more at: https://www.newlimit.com/careers *This compensation and benefits information is based on Company's good faith estimate as of the date of publication and may be modified in the future.
Benefits
- Health, dental, and vision insurance
- Paid parental leave
- Industry-leading paid time off (PTO) - 20 days/year for all employees + holidays
- NewLimit offers generous benefits to ensure our team can focus on our mission:
- NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO.
Company info
- https://www.newlimit.com/careers *This compensation and benefits information is based on Company's good faith estimate as of the date of publication and may be modified in the future.
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