Research Associate II, Bioanalytical

AskBio•Durham, NC

2d•Onsite

About The Position

Opportunity for Secondment to AskBio We’re pleased to share an exciting secondment opportunity at AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. If you’re interested in exploring this opportunity, we encourage you to: Speak with your direct manager to discuss your interest and alignment with your development goals. Apply directly using the link provided in the posting. We look forward to seeing how our colleagues continue to grow and make an impact across the Bayer-AskBio partnership. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. 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. Experience with GxP regulation and working in a regulated lab space is preferred but not required.

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