Research Associate II, Bioanalytical

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

2d•Onsite

About The Position

AskBio Inc., a subsidiary of Bayer AG, is a gene therapy company focused on developing life-saving medicines. The company has a pipeline of clinical programs for various diseases and utilizes proprietary technologies like Pro10™. With headquarters in Research Triangle Park, NC, and Edinburgh, Scotland, AskBio aims to pioneer science for transformative molecular medicines. The Research Associate II, Bioanalytical, will support pre-clinical and clinical programs by developing, qualifying, validating, and executing assays for biodistribution, viral shedding, and functional assessments. This role requires hands-on experience with nucleic acid and protein extraction and quantification, and ideally knowledge of molecular techniques for transgene expression quantification. Opportunities to learn protein assessment techniques are available. Experience with GxP regulations and regulated lab environments is preferred. This is an on-site, lab-based position in Morrisville, NC.

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 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