Scientist, Bioanalytical Sciences (LC-MS)

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

The Scientist must have technical and scientific expertise in the field of large molecule bioanalysis using LC-MS/MS. As Scientist of Bioanalytical Sciences, the individual will develop and validate bioanalytical methods to support the REGENXBIO gene therapy products pipeline. The individual will use the current available technologies and will explore novel techniques/technologies as appropriate. The Scientist will collaborate with Research and Early Development, Quality, Clinical Development, and other Departments, and may oversee Contract Research Organizations to ensure that all applicable bioanalytical test methods are appropriate for the stage of non-clinical and/or clinical development and sufficiently qualified or validated to support ongoing and future studies in alignment with regulatory expectations and industry standards

What You'll Be Doing

• Develops, qualifies and/or validates robust bioanalytical methods per Health Authority Guidance Documents using Mass Spectrometry platforms to support the Company pipeline.
• Promotes innovation and direct operational improvement and/or evaluation of new analytical techniques or technology.
• Troubleshoots and resolves bioanalytical method issues to successful resolution.
• Takes accountability and demonstrates responsibility regarding scientific study conduct.
• Ensures analytical development/validation activities conducted internally and with contracted services lead to robust methods that support bioanalytical analysis.
• Conducts technology transfer between research organization, in-house and contract laboratories.
• Serves as the Responsible/lead Scientist for the bioanalytical portion of non-regulated as well as GLP and GCP studies.
• Writes and reviews study protocols, analytical procedure, reports for regulatory submissions.
• Performs technical reviews of analytical data and be responsible for data interpretation, analysis, and reporting of results for method development and validation.
• Provides scientific and technical input to the study team and other departments.
• Ensures that any circumstances that may affect the quality and integrity of the study are identified and documented as they occur and that appropriate corrective actions are taken.
• Identifies process improvement opportunities, participates in execution of initiatives.
• Coordinates parallel tasks across multiple projects and plans, prioritizes, and manages duties to meet departmental and organizational goals.
• Mentors and/or trains new and less-experienced employees and develops training materials and schedules.
• Reviews and participates in writing of departmental Standard Operating Procedures (SOPs).
• Performs additional tasks or assist with special projects as assigned or needed.
• The Scientist will be required to maintain familiarity with scientific literature and apply it appropriately to projects (such as evaluating new methodologies and techniques)

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:

• PhD in a relevant scientific field with 2-5 years of industry or post-doc experience, or Master's with 5+ years of relevant experience.
• Strong knowledge of Mass Spectrometry; experience with Sciex instruments (7500 Triple Quad preferred).
• Familiarity with LBA and/or qPCR/ddPCR methods is a plus.
• Understanding of FDA bioanalytical guidance and regulatory expectations.
• Skilled in planning and executing experiments to meet project goals and timelines.
• Experience developing methodologies, analyzing complex data, and troubleshooting assays.
• Strong problem-solving skills with ability to interpret data and recommend next steps.
• Effective communicator-both written and verbal-with ability to tailor information for diverse audiences.
• Capable of leading projects and collaborating across teams.
• Industry experience and knowledge of gene therapy are preferred.
• Proficient in data analysis tools (e.g., SoftMax, Excel) and basic statistical methods.
• Knowledge of gene therapy is a plus.

Why You Should 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. 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.

We are proud to offer a comprehensive rewards package which includes a market-competitive base salary, an annual performance-based bonus program, stock grants at all levels, and benefits such as health, dental, and vision insurance, retirement plan with 401(k) match, summer hours, and more! The estimated compensation range for this role is $98,000 to $133,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.