Scientist I/II, Bioanalytical Sciences

Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The Opportunity

We are in search of a collaborative, passionate scientist with experience in the field of bioanalytical sciences for biologics. As Scientist, Bioanalytical Sciences, you will have the opportunity to develop and validate bioanalytical methods to support the development of gene therapy products at REGENXBIO.

The ability to work well cross-functionally is a must! You will collaborate with colleagues in BioA Sciences, Nonclinical Sciences, Research & Early Development, Quality, and contract research labs to ensure that all applicable bioanalytical test methods are appropriate for the stage of clinical development and sufficiently qualified and/or validated in a timely manner.

What You'll Be Doing

• Contribute to the development, validation, and implementation of ligand-binding assays (LBA) for quantifying biotherapeutic proteins, biomarkers, and assessing immunogenicity in both regulated and non-regulated environment.
• Act as research scientist, in a teamwork setting, to actively participate in project team activities, and is responsible for reporting and interpreting bioanalytical results to support drug discovery and development activities.
• Work on complex problems in which analysis of situations or data require an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Develop, qualify and validate PK/PD/immunogenicity assays and perform- as needed - subsequent analysis of PK/PD/immunogenicity study samples.
• Summarize bioanalytical results, prepares departmental SOPs, and writes technical reports in support of internal and regulatory filing.
• Represent bioanalytical department in cross-functional discussions and presents scientific findings at the team meetings and external meetings. 

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

• A PhD in a scientific discipline is preferred; Equivalent experience may be accepted with minimum of 5 years work experience in a regulated bioanalytical environment.
• Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.
• Must have hands-on experience in ligand-binding assay (LBA) development, execution and ability to troubleshoot assay performance
• Working knowledge of methods and immunoassay technologies used for large molecules (biologics) analysis, such as ELISA (direct and indirect sandwich formats), Luminescence, Colorimetric, Electrochemiluminescence (MSD), etc. to support preclinical and clinical studies.
• Hands-on experience with regulated Mass Spectrometry (LC-MS/MS) platform is preferred.
• Understanding of the immune system, antibody assays, and experience with clinical and preclinical studies is required. Working knowledge of GLP, GCP, Bioanalytical and Immunogenicity Guidance (FDA/EMA) is required.
• A working knowledge of protein biochemistry and characterization would be beneficial.
• Willingness to learn and become a subject matter expert.
• Strong verbal and written communication skills are required.
• Must be goal-oriented, quality-conscientious, and customer- focused.
• Good compliance and safety practices are a must.
• Must be experienced in working in a team-focused environment.

Why Should You Apply?

By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.

We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!

In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.