Scientist I, Analytical Development (Bioassay)

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking a highly motivated early career scientist to join the dynamic and growing analytical development team. He/she will mainly be responsible for assisting with the development of phase-appropriate bioassays that will be used for drug substance and drug product stability and lot release testing as well as characterization studies. He/she will also participate in exploratory studies that will evaluate and introduce new technologies to existing assay platforms.

Responsibilities

• Plan and execute experiments that contribute to bioassay development, optimization, qualification/validation of bioassays suitable for drug product stability studies and lot disposition.
• Assist in authoring of technical reports and SOPs.
• Support tech transfer of methods to internal QC group and/or CROs.
• Work with junior research associate on experimental design, troubleshooting, assay optimization and data interpretation as needed.
• Interpret and present data at group and department meetings.
• Collaborate within Bioassay group and provide support to collaborating functional groups as needed.
• Participate in exploratory assay development efforts to bring new technologies or assays to Analytical development.

Qualifications

• B.S or M.S. in Cell Biology, Molecular Biology or related discipline.
• B.S. with 5-10 years or M.S. with 2-5 (no more than 5 years) of biopharma industry experience.
• Experience with cell culture and conducting cell-based assays in 96-well setting is a must.
• Knowledge and hands-on experience with various analytical methods (e.g. Fluorescence In situ hybridization, immunofluorescence microscopy, FACS, ELISA, MSD, plate reader).
• Ability to troubleshoot experiments based on a thorough understanding of assay principles.
• Experience and understanding of phase-appropriate analytical assay development, qualification, and validation obtained from 1-2 years of experience in GxP environment is a significant plus but not required.
• Experience with high-content imaging and image analysis is a plus but not required.
• Ability to work in a fast-paced team-orientated environment.
• Excellent written and verbal communication skills.
• Familiarity with virology is a plus.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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