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 be a technical and scientific expert in the field of genomic analyses in bioanalytical sciences for biologics. As Scientist of Bioanalytical Sciences, the individual will develop and validate genomics bioanalytical methods (eg. molecular assays using qPCR, ddPCR, or RT-PCR, as well as LC-MS, Lignad Binding Assays (LBA), etc) 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 biochemical technique (qPCR, ddPCR, LBA, LC-MS/MS etc) 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 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 polymerase chain reaction (PCR) including both qPCR and dPCR, experience using commercially available PCR machine, and ability to design primers/probes sets.
- Knowledge/hands-on experience with LC-MS 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
- Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.)
- Must be able to work collaboratively and effectively as part of a team
- Prior industry experience preferred
- Familiarity with statistical analysis tools and able to apply the basic statistic tools desired.
- 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
- dPCR
- qPCR
- Assay Development & Validation
- LBA and LC-MS/MS a plus
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. Apply for this job
