Scientist II (Biochemistry – Molecular bio)

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking an experienced and exceptional Scientist to join the dynamic and growing analytical team to establish robust assays suitable for lot disposition and characterization of gene therapy drug products and substances.

The individual will play a crucial role for the development and optimization of such assays using methodologies of biology, biochemistry, biophysics and/or molecular biology. He/she will lead the development of assays for the characterization of biomolecule interactions and participate (or lead) method qualification/validation in a cGMP setting. Successful candidates will have extensive experience in the development of robust assays and will be a fast-learner with passion for new technology and science.

Responsibilities

• Develop, optimize and troubleshoot lot release and characterization assays with minimal supervision applying methodologies of biology, biochemistry, biophysics or molecular biology. Specifically, lead the development of assays that can measure and/or characterize biomolecule interactions (protein-protein, protein-nucleic acid, protein-virus).
• Contribute to optimization and troubleshooting of bioassays and PCR-based assays using a variety of platforms including but not limited to ELISA, MSD, high-content imaging, luminescent/fluorescent plate reader, and qPCR/ddPCR.
• Drive experimental design and execution by understanding the purpose, rigidly following through every step of execution, thoroughly analyzing data, ensuring the data quality and presenting data in a logical and scientific manner.
• Contribute to qualification and validation of lot release assays by authoring SOPs, study protocols and reports. Additionally, participate in the execution of the qualification/validation activities as an analyst.
• Evaluate applications of new and innovative technology platforms and lead the implementation of approved new technology platforms in-house by proactively researching the market, interacting with SMEs in the field and working with vendors.
• Take ownership of maintaining clean and fully functional lab space as a good citizen of the lab.
• Collaborate with R&D for knowledge transfer during assay development and work closely with QC for method transfer. Be actively involved (both as trainee and trainer) in cross-training of lab personnel.

Qualifications

• M.S in biology/biochemistry discipline is required and Ph.D degree is a significant plus.
• Minimum 5 years of biopharma industry experience is required for M.S and 0-2 years of biopharma industry experience is required for Ph.D.
• Deep understanding of biomolecule interactions (protein-protein, virus-protein) and demonstrated track record of characterizing such interactions. Extensive experience in successfully developing/optimizing label-free binding assays using SPR or Octet is a significant plus.
• Ability to develop automation protocols using liquid handling system (e.g. Hamilton) is a big plus.
• Broad experiences in cellular, biochemical and molecular biological methods including but not limited to cell culture, PCR/qPCR/ddPCR, immunostaining, ELISA/MSD, flow cytometry, protein gel, and Western blot.
• Basic understanding of regulatory agency guidance such as FDA, ICH and EMA and hand-on experience is not required but a big plus.
• Enjoy learning and challenges. Especially, must be able to learn new instrument and master their software quickly.
• Ability to work in a fast-paced team environment and to prioritize work from multiple projects. Must be highly reliable and goals/deadlines oriented.
• Intelligent individual who respects others and is open to new/different ideas.
• Must have exceptional organizational skills.
• Excellent written and verbal communication skills.

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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