Senior Associate Scientist/Scientist, 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 Scientist will serve as a bioanalytical expert, developing and validating methods to support REGENXBIO's gene therapy pipeline. This role leverages current and emerging technologies, collaborates across internal teams and external partners, and ensures bioanalytical methods meet regulatory and industry standards for all stages of development.

• Develops, qualifies and/or validates robust bioanalytical methods per Health Authority Guidance Documents using biochemical technique (qPCR, ddPCR, ligand binding assays) 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.
• 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)

• PhD in relevant scientific discipline with 1+ years of industry or post-doctoral experience or Master's degree in relevant scientific discipline with 5+ years of relevant experience
• Solid understanding of polymerase chain reaction (PCR) including both qPCR and ddPCR, experience using commercially available PCR machine, and ability to design primers/probes sets.
• Strong knowledge of FDA and global bioanalytical assay guidance.
• Skilled in independently designing and executing experiments to meet project goals.
• Experienced in developing and validating assays (dPCR, qPCR, LBA, LC-MS/MS) and performing advanced data analysis.
• Proficient in interpreting results, troubleshooting, and recommending next steps.
• Effective communicator with strong presentation and technical writing skills.
• Capable of leading cross-functional and external collaborations.
• Team-oriented with proven problem-solving abilities.
• Proficient in statistical tools and software (SoftMax, MS Office).
• Industry experience preferred; gene therapy knowledge a plus.
• LBA and LC-MS/MS 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 $104,000 to $141,000 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.