Scientist, Bioanalytical Sciences (LC-MS)

About the position

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 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.

Responsibilities

• 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.
• Maintains familiarity with scientific literature and applies it appropriately to projects.

Requirements

• PhD in relevant scientific discipline with 2-5 years of industry or post-doctoral experience or Master's degree in relevant scientific discipline with 5+ years of relevant experience.
• Solid understanding of Mass Spectrometry platforms and working knowledge of Sciex instruments (7500 Triple Quad preferred).
• Knowledge/hands-on experience with LBA and/or qPCR/ddPCR methods is a plus.
• Working knowledge of relevant bioanalytical FDA guidance documents and health authorities expectations of bioanalytical assays.
• Ability to independently plan experiments, willingness to solicit feedback and guidance to ensure proposals align with project needs.
• Ability to perform and execute experiments in a timely fashion to support scientific activities and project goals/deliverables.
• Ability to develop a wide range of methodologies/technologies and perform advanced data analysis.
• Ability to recommend alternatives as well as research new methods and techniques.
• Demonstrated ability to analyze and resolve problems, troubleshoot assay issues.
• 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, reports, etc.).
• Ability to lead internal and external functional projects.
• Must possess excellent oral and written communication skills.
• Ability to present technical information to both technical and non-technical audience is required.
• Good computer skills and working knowledge of SoftMax or other data analysis software, MS word, Excel, Power Point are required.
• Knowledge of gene therapy is a plus.

Nice-to-haves

• Prior industry experience preferred.
• Familiarity with statistical analysis tools and able to apply the basic statistic tools desired.

Benefits

• Market-competitive base salary
• Annual performance-based bonus program
• Stock grants at all levels
• Health insurance
• Dental insurance
• Vision insurance
• Retirement plan with 401(k) match
• Summer hours
• Professional development resources