Scientist, Analytical Development (Characterization)
Rockville, MD, United States
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.
Develop and optimize robust biophysical characterization methods for analytically assessing AAV product quality including particle size analysis, analytical ultracentrifugation, and thermodynamic analysis.
Draft and review technical documents including SOPs, analytical method development/qualification/validation/transfer documents, and supporting documents for regulatory submissions.
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.
Present scientific findings at internal and external meetings.
Maintain understanding of global expectations for gene therapy products in terms of analytical characterization, testing and release methodology, and developments in the field.
Evaluate new analytical methods/instruments and make recommendations regarding their use.
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 6+ years of relevant industry experience or PhD in relevant scientific discipline with/without post-doctoral 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.
Experience working in a GMP or GLP environment.
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 identify and solve technical challenges.
Able to determine methods and procedures and communicate them to others.
Ability to recommend alternatives as well as research new methods and techniques.
Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.).
Prior industry experience preferred.
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.
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