Principal Scientist, Process Development - Analytical

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.

Principal Scientist, Process Development - Analytical, is responsible for leading the development, optimization and execution of phase-appropriate analytical assays used for testing and characterization of drug substance/drug product as well as in-process pool product quality attribute and concentration testing.

Responsibilities

• Provides analytical testing support across the entire process (e.g. upstream, downstream, drug product) in support of exploratory studies targeted at developing, demonstrating and characterizing new technology platforms and innovative upgrades for existing platforms.
• Oversee analytical method development, transfer and testing support in the TR&D laboratory
• Work with QC and/or Analytical Sciences group to align analytical methods and transfer analytical methods between TR&D labs and QC and/or Analytical Sciences labs
• Supervise in-process and drug substance/drug product assays
• Oversee analytical method development, transfer and routine testing
• Design, perform, and guide lab experiments in support of AAV process development and process characterization studies using some of the following techniques: ddPCR, qPCR, ELISA, analytical ultracentrifugation, spectrophotometry, particle analysis, HPLC, CE, SDS-PAGE, and Western blot.
• Oversee and approve experimental protocols/reports and related to analytical methods
• Lead assay troubleshooting and method performance improvement projects
• Serve as subject matter expert and represent TR&D laboratory in cross-functional teams (QC, Analytical Sciences, Technical Development, Manufacturing Sciences and Technology, etc.)
• Collaborate with and oversee contract testing labs to ensure successful completion of testing projects
• Manage the justification, selection and use of scientific equipment and instrumentation, computer systems
• Develop and manage system for test sample forecasting, submission, progress tracking, and results reporting
• Participate in exploratory assay development efforts to bring new technologies or assays to the Analytical Development department.
• Other related job duties as assigned.

Qualifications

• Bachelor's in chemistry, analytical chemistry, molecular biology, biochemistry or a related technical field with 10 years experience or Master's with 8 or PHD with 6.
• Expert knowledge of scientific principles and concepts. Reputation as emerging leader in field with sustained performance and accomplishment.
• Experience, with knowledge and hands-on development with various analytical methods may include but are not limited to, ddPCR, qPCR, Western Blot, ELISA, MSD, HPLC, Capillary Electrophoresis, ELISpot, Flow Cytometry/FACS, Luminescence/Fluorescence plate-based assays, Immunofluorescence microscopy.
• Demonstrated proficiency in developing and optimizing assays independently with limited guidance.
• Demonstrated ability to collaborate in a fast-paced, multi-site, team-orientated environment with aggressive timelines.
• Excellent written and verbal communication skills.
• Experience and understanding of phase-appropriate analytical assay development, qualification, and validation in GxP environments.
• Experience with analytical and/or statistical software (e.g., JMP, Softmax Pro, XLfit, Gen5 etc.)
• Ability to direct the troubleshooting of experiments based on thorough understanding of assay principles.
• Demonstrated experience leading a team of highly motivated scientists.

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-AR1