Principal Scientist, Analytical Science and Technology (Global QC)

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.

This posting is for multiple positions within the Analytical Science and Technology (AST) group. The level of the position will be dependent on candidate's education and experience.

The Principal Scientist role provides global support for analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation. Potential candidate is expected to be familiar with some of the following subjects and techniques:

• In depth knowledge in protein/nucleic acid chemistry/biochemistry
• Basic molecular biology knowledge
• Familiar with GMP requirement and regulations (FDA/EMA/ICH etc.)
• Chromatography (RP, SEC, IEX, HILIC etc.)
• ELISA
• Cell based bioassay (potency, infectious titer assay etc.)
• PCR (qPCR, ddPCR etc)
• Analytical ultracentrifugation
• Spectroscopy (UV, fluorescence, FTIR) and other biophysical techniques
• Mass spectrometry (esp. ICP-MS)
• Particle analysis

As gene therapy is still an emerging/fast progressing field, passion for continuous learning and capability to work in a highly dynamic, fast pace, collaborative environment is key to the success of this role.

Responsibilities

• Design and perform lab experiments independently
• Serve as subject matter expert and represent AST in cross-functional teams (CMC, Regulatory, Quality, Manufacturing etc.) across network
• Act as analytical technical lead for one or more projects
• Collaborate with Analytical Development group to transfer/co-qualify new methods
• Oversee contract testing labs to ensure successful completion of projects to the standards of AveXis
• Author experimental protocols/reports and regulatory submissions related to analytical
• Lead assay troubleshooting and projects to improve method performance across network
• Lead OOS investigation and other non-conforming results and implement appropriate corrective and preventative actions
• Technical mentor within the team
• Support specification, comparability setting strategy
• Contribute to response to agency questions related to analytical methods/specification
• Manage the use and maintenance of scientific equipment and instrumentation, computer systems.

Qualifications

• BS with 10+, MS 8+, Ph.D. 5+ years biopharmaceutical industry experience,
• Strong critical thinking and problem-solving skills
• Experience in leading method development, transfer, qualification, validation and troubleshooting
• Experience in gene/cell therapy field is a plus
• An excellent and persuasive communicator.
• Energetic, flexible, collaborative and proactive.
• Strong communication, scientific writing and presentation 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. #LI-MG1