Scientist II/Senior Scientist

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 and competent Scientist to join the growing, dynamic multidisciplinary Analytical Development department. The person will contribute to the development and optimization of phase-appropriate molecular bioassays for the lot release, stability testing and characterization of drug substance/drug product. In addition, he/she will participate in exploratory studies driving the evaluation of state-of-the-art new technology platforms, and innovative upgrades for existing assay platforms.

Responsibilities

• Independently design and execute experiments (with some supervision) for the development, optimization, qualification of robust molecular assays (i.e. NGS, qPCR, ddPCR and/or other molecular assay platforms) for DNA characteristics such as genomic integrity and residual packaged impurity DNA, suitable for the characterization and lot disposition of AAV-based gene products in the AveXis pipeline.
• Analyze data with applicable bioinformatics tools/scientifically sound interpretation and present data at group/departmental meetings
• Assist in authoring of technical reports and SOPs associated with the molecular assays developed and qualified
• Serve as SME of molecular assays in support of technology transfer of methods to internal QC group and/or CROs and subsequent trouble-shooting, as needed
• Collaborate within the Analytical Development-Molecular group and provide support to collaborating functional groups, as needed
• Participate in exploratory assay development efforts to bring new technologies or assays to the Analytical Development department
• Work with junior research associates on experimental design, troubleshooting, assay optimization and data interpretation, if applicable.

Qualifications

• Ph.D. in Molecular Biology or related discipline, such as Immunology, Cellular Biology or Genetics
• Relevant Biopharma industry experience:
  • Scientist II: Ph.D. with 3-5 years
  • Senior Scientist: Ph.D. with > 5 years
• Knowledge and hands-on experience with various molecular biology analytical methods
  • For example, DNA/RNA isolation, primer design, end point PCR, qPCR, qRT-PCR, droplet digital PCR, Sanger sequencing, next-generation sequencing (NGS)
• GXP experience preferred, but not required.
• Proficiency with various molecular biology and sequence analysis softwares
  • For example, Geneious, Applied Biosystems 7500, QuantaSoft
• Experience with bioinformatics programming (e.g., Python, R, etc.), is a plus
• Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.), is highly beneficial
• High level of proficiency with Cell Culture standard methods such as aseptic technique, cell culture media preparation, maintenance of mammalian cell lines and cryopreservation
• Demonstrated proficiency in developing and optimizing molecular bioassays independently with limited guidance
• Ability to obtain frontier scientific knowledge and skills by learning from literature or conferences
• Demonstrated ability to work in a fast-paced, team-orientated environment with aggressive timelines
• Excellent written and verbal communication skills
• 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
• Ability to troubleshoot experiments based on thorough understanding of assay principles
• 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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