Regenxbio Inc.
Scientist I/II, Bioanalytical Sciences
Regenxbio Inc., Rockville, Maryland, us, 20849
Who we areREGENXBIO 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.What you'll be doing
Contribute to the development, validation, and implementation of ligand-binding assays (LBA) for quantifying biotherapeutic proteins, biomarkers, and assessing immunogenicity in both regulated and non-regulated environments.Act as a research scientist in a teamwork setting, actively participating in project team activities, and responsible for reporting and interpreting bioanalytical results to support drug discovery and development activities.Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.Develop, qualify, and validate PK/PD/immunogenicity assays and perform subsequent analysis of PK/PD/immunogenicity study samples as needed.Summarize bioanalytical results, prepare departmental SOPs, and write technical reports in support of internal and regulatory filing.Represent the bioanalytical department in cross-functional discussions and present scientific findings at team meetings and external meetings.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:
A PhD in a scientific discipline is preferred; equivalent experience may be accepted with a minimum of 5 years work experience in a regulated bioanalytical environment.Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.Must have hands-on experience in ligand-binding assay (LBA) development, execution, and troubleshooting assay performance.Working knowledge of methods and immunoassay technologies used for large molecules (biologics) analysis, such as ELISA (direct and indirect sandwich formats), luminescence, colorimetric, electrochemiluminescence (MSD), etc., to support preclinical and clinical studies.Understanding of the immune system, antibody assays, and experience with clinical and preclinical studies is required. Working knowledge of GLP, GCP, Bioanalytical, and Immunogenicity Guidance (FDA/EMA) is required.A working knowledge of protein biochemistry and characterization would be beneficial.Willingness to learn and become a subject matter expert.Strong verbal and written communication skills are required.Must be goal-oriented, quality-conscious, and customer-focused.Good compliance and safety practices are a must.Must be experienced in working in a team-focused environment.
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Contribute to the development, validation, and implementation of ligand-binding assays (LBA) for quantifying biotherapeutic proteins, biomarkers, and assessing immunogenicity in both regulated and non-regulated environments.Act as a research scientist in a teamwork setting, actively participating in project team activities, and responsible for reporting and interpreting bioanalytical results to support drug discovery and development activities.Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.Develop, qualify, and validate PK/PD/immunogenicity assays and perform subsequent analysis of PK/PD/immunogenicity study samples as needed.Summarize bioanalytical results, prepare departmental SOPs, and write technical reports in support of internal and regulatory filing.Represent the bioanalytical department in cross-functional discussions and present scientific findings at team meetings and external meetings.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:
A PhD in a scientific discipline is preferred; equivalent experience may be accepted with a minimum of 5 years work experience in a regulated bioanalytical environment.Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered.Must have hands-on experience in ligand-binding assay (LBA) development, execution, and troubleshooting assay performance.Working knowledge of methods and immunoassay technologies used for large molecules (biologics) analysis, such as ELISA (direct and indirect sandwich formats), luminescence, colorimetric, electrochemiluminescence (MSD), etc., to support preclinical and clinical studies.Understanding of the immune system, antibody assays, and experience with clinical and preclinical studies is required. Working knowledge of GLP, GCP, Bioanalytical, and Immunogenicity Guidance (FDA/EMA) is required.A working knowledge of protein biochemistry and characterization would be beneficial.Willingness to learn and become a subject matter expert.Strong verbal and written communication skills are required.Must be goal-oriented, quality-conscious, and customer-focused.Good compliance and safety practices are a must.Must be experienced in working in a team-focused environment.
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