Senior Associate Scientist, Analytical Development (characterization)

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 looking a qualified scientist with sound scientific knowledge and excellent technical skills in analytical sciences for biologics. You will be responsible for performing routine analytical tests and develop analytical methods independently. You also will be responsible to develop release, characterization, and in-process assays to support the development and manufacturing of AAV based gene therapy products. In this role, you will collaborate across multiple groups including Process Development, Quality, Formulation, Research, as well as CMOs and CTLs to ensure that all applicable analytical test methods are appropriate for the stages of clinical development.

What you’ll be doing

• Collaborate with a team of scientists and associates to implement analytical methods and provide analytical support for in-house and contract labs for AAV-based gene therapy products.
• Perform routine analysis using biophysical methods to support release and characterization of AAV products.
• Perform assay qualification/validation and analytical tech transfer appropriate for the stages of clinical development. These methods may include analytical ultracentrifugation, light scattering, and differential scanning fluorimetry assays.
• Make detailed observations, analyze data, interpret results, prepare reports, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.
• Maintain effective communication with managers, analytical groups, and cross-functional teams.
• Keep detailed and accurate testing records.
• Troubleshoot and resolve analytical method and instrument issues to successful resolution.

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:

• Bachelor’s degree in relevant scientific discipline with at least 8+ years relevant industry experience or Master’s degree in relevant scientific discipline with 5+ years of relevant industry experience or PhD in relevant scientific discipline with no industry experience.
• Experience in analytical ultracentrifugation (SV-AUC), particle size analysis (DLS and NTA), and thermodynamic analysis (DSF and DSC).
• Experience in analytical method development, tech transfer, method qualification and validation is highly desired.
• Experience drafting and reviewing technical documents including analytical method development/qualification/validation/transfer documents and SOPs.
• Ability to independently plan and perform experiments for assay development, product release/stability/characterization, support for project activities with minimal supervision.
• Ability to interpret data, draw conclusions, and recommend next steps.
• Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.).
• Prior industry experience preferred.