Job Description

Job Responsibilities:

• Conducting experiments to characterize adeno-associated viral nanoparticles for gene therapy products.
• Performing assays for particle/protein/DNA in multiple assays (Capillary Electrophoresis, SDS-PAGE, DLS, Western Blot, Light Obscuration, AUC, RP, SE – HPLC methods, etc.) to assist in evaluation of product characterization, including but not limited to: process change, formulation study, stability study using statistical methods as needed, following SOPs and execute experiments according to guidelines.
• Developing new assays and transfer to QC, Process Development, and Research.
• Developing new analytical tools to characterize adeno associated viral nanoparticles for gene therapy products
• Participating in writing, reviewing, and editing experimental procedures and reports
• Maintaining accurate records of all analytical development activities timely
• Analyzing and determining the applicability of laboratory data to draw conclusions and to make appropriate recommendations

Skills:

• Direct, hands-on experience with adeno-associated viral nanoparticles.
• Experience operating chromatography methods (HPLC, etc.) and proficient understanding of chromatography software.
• Experience operating general ultracentrifugation methods.
• Experience operating PCR methods.
• Experience in analytical method development and assay transfer.
• Experience in statistical analysis with proficiency in statistical analysis software.

Education/Experience:

• Bachelor of Science with 2+ years of experience working in a pharmaceutical or biotech company and with the requisite years’ of experience employing the skills listed in the job description (for each level) performing multiple assays for bioproducts.

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