Scientist II, Process Science (Upstream)

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.

The successful candidate will be an integral part of a fast paced and rapidly growing group of scientists and engineers developing production and purification processes for the manufacture of our proprietary gene therapies.

The Scientist II is responsible for contributing to the development and improvement of the upstream manufacturing platform processes used to manufacture AveXis gene therapy products. This individual will lead and support activity with cross-functional organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. This role will provide support for process, analytical, and characterization knowledge related to the production of AveXis gene therapy products, and the raw materials needed to make them.

Responsibilities

• Develop, refine, optimize and characterize cell culture and vector production processes. Execute experiments and troubleshoot process and equipment as needed.
• Conduct laboratory studies to enhance AAV manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
• Implement novel cell culture strategies to support robust recombinant protein expression.
• Create and revise SOPs for equipment and process operations as needed.
• Author technical reports and CMC sections for regulatory filings.
• Ensure all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory filings production of virus or biologics from mammalian expression systems.
• Support initiatives for new technology development and continuous improvement projects.
• Maintain constant awareness of novel biochemical and biophysical technologies for AAV production and characterization. Keep up to date with the scientific literature and developments in the field.
• Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments. Justifies development strategies and experiment designs.

Qualifications

• Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field; Master's degree or PhD preferred.
• 3-5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture.
• Proven expertise with a variety of cell culture and bioreactor technologies and scale-down model. Experience with development of cell culture systems for the production of viral vectors or vaccines is a plus.
• Should be highly motivated, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
• A track record of collaborative relations with groups such as research & development, analytical development, and pilot scale operations.
• Must demonstrate a keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.
• Demonstrated ability to work effectively in a cross-functional team.
• Ability to multi-task and meet tight timelines is essential.
• Excellent oral and written communication skills.
• Approximately 10% to 25% travel may be required.

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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