About Audentes Therapeutics
Audentes Therapeutics (NASDAQ:BOLD) is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We are a focused, experienced and passionate team driven by the goal of improving the lives of patients. We currently have four programs in development for the treatment of X-Linked Myotubular Myopathy (XLMTM), Crigler-Najjar Syndrome, CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and Pompe disease. We are a focused, experienced and passionate team driven by the goal of improving the lives of patients.
Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what were looking for, wed love to hear from you. Our compensation philosophy embodies what youd expect from an innovative life sciences employer competing for the best talent available.
Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes mission.
The Research Associate III will implement nonclinical and clinical bioanalytical assays for AAV gene therapy products by executing assay development, verification, validation, and standardization. Reporting into the Scientist II, Clinical Bioanalytics, the Research Associate III will be located in our South San Francisco R&D laboratories.
The specific responsibilities of this position include:
Development, Qualification/Validation, and Execution of clinical assays for anti-drug antibodies in compliance with appropriate quality and regulatory standards, including GLP/GCLP/CLIA.
Development, Qualification/Validation, and Execution of clinical assays for immune cell activation (ELISPOT) in compliance with appropriate quality and regulatory standards, including GLP/GCLP/CLIA.
Responsible for preparation and presentation of data/reports from bioanalytic lab findings
Responsible for preparation of technical reports related to assay development, qualification, and/or validation.
Work closely with other functional areas and colleagues to insure that all studies are performed in a quality, timely and scientific manner.
Contribute to the preparation of bioanalytical sections of IND/BLA documents.
Provide bioanalytical input and collaborate across all functional areas, including R&D, QC preclinical, clinical development, project management, biostatistics, and regulatory affairs departments.
Required Education, Skills and Experience
Bachelors degree in biology, biochemistry or relevant discipline with a minimum of 5-8 years experience as a research associate or Masters degree with a minimum of 3-5 years experience as a research associate conducting bioanalytical research and development, and sample analysis for R&D, nonclinical and clinical assays of in vivo endpoints.
2-5 years experience demonstrating expertise in applicable bioanalytical assays and cell culture.
Demonstrated expertise in working in compliance with relevant regulatory standards, including GLP, GCLP, and/or CLIA.
Demonstrated success in technical proficiency, scientific creativity, and collaboration with others and independent thought.
Excellent written and oral communications skills.
Scientific know-how: up to date with novel technical development (conferences, scientific literature).
A history of being a driver of innovative scientific research and development on bioanalytics.
A proven self-starter with excellent time and people management capabilities and who is seeking to be a critical part of cross functional teams to support the companys drug development process.
Demonstrated pragmatic ability to execute on goals, proven systematic drug development thinking, exceptional writing and strong communication skills and a successful history of working independently in a dynamic and cross-functional company.
Proficient in the use of Microsoft Word, Excel and PowerPoint and GraphPad.
Preferred Skills and Experience
AAV and gene and/or cellular therapy experience.
2 years experience in FACs analysis.
Experience in ELISPOT