Research Associate II, Bioanalytical

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

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.

Position Summary

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.

Job 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

Minimum 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

Preferred Education, Experience, and Skills

• 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

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at [email protected].

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.