The Assocciate Scientist must be a technical and scientific expert in the field of bioanalytical sciences for biologics. As Associate 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.
Develops, qualifies and/or validates robust bioanalytical methods (cell-based and/or ligand binding assays) to support the Company pipeline.
Troubleshoots and resolves bioanalytical method issues to successful resolution.
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.
Promotes innovation and direct operational improvement and/or evaluation of new analytical techniques or technology.
Serves as the Responsible 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.
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.
Identifies process improvement opportunities, participates in execution of initiatives.
Takes accountability and demonstrates responsibility regarding scientific study conduct.
Reviews and participates in writing of departmental Standard Operating Procedures (SOPs).
Performs additional tasks or assist with special projects as assigned or needed.
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
PhD/MS/BS in biochemistry, molecular biology, immunology, biotechnology, or related field with a minimum of 2+ years’ research experience in industrial laboratory environment, respectively.
Knowledge with gene therapy is a plus.
Must have prior experience and demonstrated ability to develop immunoassays (such as ELISA, ECL etc) and/or cell based assays.
Experience with execution of Pharmacokinetics Assays, Cell-based Assays, Immunogenicity Assays, and Biomarkers Assays.
Demonstrated ability to analyze and resolve problems.
Strong technical competency, organizational and prioritization skills.
Must work effectively within team to meet objectives under time constraints.
Knowledge and application of regulatory guidance and white papers to experimental planning and design
Prior experience working in regulated environment and knowledge of GxP as they apply to laboratory practices
Must possess excellent oral and written communication skills.
Ability to present technical information to both technical and non-technical audience is required
Strong hands on skills with Cell-Based and/or Ligand Binding Assays (such as ELISA, MSD-ECL, ELISPOT etc.) development and validation.
Strong technical expertise in areas such as Pharmacokinetics Assays, Cell-based Assays, Immunogenicity Assays, Biomarkers Assays and the respective bioanalytical technologies.
Familiarity with statistical analysis tools and able to apply the basic statistic tools.
Good computer skills and working knowledge of SoftMax or other data analysis software; MS word, Excel, Power Point are required.
Experience with qPCR is a plus.
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
This is a laboratory role which requires physical mobility (e.g., sitting or standing for extended periods of time), physical effort (e.g., lifting, carrying, or pushing ~ 40 pounds), sensory requirements (e.g., distinguish colors), and chemical exposure.
Supervisory responsibility of a team of 2-5 bioanalytical scientists/research associates
Internal Number: RE-18-00004
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.
Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our gene therapy product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes. We are currently developing gene therapy product candidates for the treatment of retinal, metabolic, and neurodegenerative diseases. Our product candidates all utilize AAV viral vectors from our proprietary gene delivery platform, which we call our ...NAV Technology Platform. In addition to our internal product candidate programs, we also selectively license our NAV Vectors to other leading biotechnology companies.