Research Associate II, Bioanalytical

Asklepios BioPharmaceutical, Inc. (AskBio) • Durham, NC

75d

About The Position

The Research Associate II, Bioanalytical, will report to the Director, Translational Biomarkers, and will participate in the development, qualification, validation, and execution of assays investigating biodistribution, viral shedding, and functional assessments in support of pre-clinical and clinical stage programs. This is an on-site lab-based position in Morrisville, NC and prior experience with methods for extraction and quantification of nucleic material (DNA, RNA) and protein is required. The ideal candidate would have knowledge of various molecular techniques to quantify transgene expression. Candidates may also have opportunities to learn different techniques for protein assessment.

Requirements

• Master’s degree in biology, chemistry or related field OR bachelor’s degree in biology, chemistry, or related field with 2+ years’ relevant work experience OR High School Diploma and 6+ years’ relevant work experience
• Hands-on experience with the processing of, and isolation of nucleic acids and protein from, material acquired from different species and organ types
• Demonstrated understanding of assay qualification and/or validation requirements
• Possess knowledge of, and experience with, multiple assays including: ddPCR, RT-ddPCR, ELISA, western blots, and/or MSD-based platforms
• Excellent technical lab skills with attention to detail and the ability to assume independent ownership of workflows
• Knowledge of GxP regulatory requirements
• Ability to multitask among multiple projects and teams, and work in a fast-paced, highly interactive environment
• Self-motivated, organized, and capable of troubleshooting independently
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Excellent communication skills with ability to collaborate with colleagues across multiple communication platforms including e-mail, Microsoft Teams, and Sharepoint sites

Nice To Haves

• Hands-on experience with assay qualification and validation
• Prior work in a regulated lab environment
• Familiarity with software such as Softmax Pro, graphpad prism, and smartsheet
• Prior use of LIMS sample management software and/or lab automation
• Relevant knowledge and industrial experience with gene therapy, including AAV and/or lentiviral-based platforms

Responsibilities

• Isolate and quantify nucleic acids and proteins from various model systems and tissue types
• Participate in assay design, including assay qualification and validation
• Utilize molecular techniques including, but not limited to gene expression analysis, primer probe set design/validation, ddPCR, RT-ddPCR, ELISA, western blots, and MSD for sample analysis
• Responsible for co-authoring and reviewing test methods, work plans, SOPs, and qualification/validation reports
• Contribute to data review and quality control of data in support of regulatory filings
• Perform routine instrument maintenance and performance verification
• Maintain organized electronic and/or paper-based documentation that is fit-for-purpose with regards to regulatory requirements
• Receive, accession, and manage samples using LIMS
• Perform data analysis and effectively communicate results in formal reports and presentations for technical discussions
• Maintain inventories and/or place orders of reagents and materials needed for the assigned projects allowing for timely execution of related lab work
• Ensure lab areas are clean and organized, and that equipment, supplies, and raw materials are available for use

What This Job Offers

• Education Level: Master's degree
• Number of Employees: 501-1,000 employees