Senior Scientist, Assay Support

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 Senior Scientist, Assay Support who will play a crucial role in experimental design, execution and data interpretation of bioassays for sample testing and in the support of bioassay development and optimization. The candidate must have in-depth knowledge of cell biology and a track record of working in cell-based assay optimization, routine assay execution and management under GxP environment. The ability to quickly learn, meet tight timeline, manage two or more direct reports, efficiently communicate, multi-task with excellent organization skills is extremely important to successfully fulfill responsibilities.

Responsibilities

• Lead and manage studies performed using established bioassays.
  • Design experiments using proper standards and controls to support various studies such as process development, formulation study, lab investigation and troubleshooting.
  • Plan assay execution and assign to direct reports. Explain the study and plan and ensure quality data are generated. Hands-on execution of assays is also expected.
  • Interact with collaborators to discuss planning and to report data; help managers with assessing sample priorities and lab capacity.
  • Interpret data, put together slide deck and present data in meetings to represent the team and Bioassay group.
  • Troubleshoot and determine root cause of issues in assay performance.
• Support assay development/optimization and other proof of concept studies.
  • Establish technology platforms (e.g. western blot, qPCR) and serve as SME for these platforms. Develop assays and build testing capacity as needed.
  • Design/execute experiments as needed using various techniques to support proof of concept studies and ad-hoc experiments.
  • Manage cell banking activities and other critical reagents programs.
  • Help direct reports develop technically solid automation protocols.
• Lead/Contribute to GxP workflow within the Bioassay group.
  • Lead or contribute to drafting of SOPs and other technical documents such as study protocols and reports.
  • Establish control trending and monitor performance of various assays.
• Manage 2 or more direct reports by providing technical and scientific oversight and mentoring to help grow their career.
• Manage lab operation by overseeing lab instrument/inventory, ensuring lab safety and serving as the point of contact person for such matters (e.g. interaction with facility).

Qualifications

• Bachelor's degree and must have minimum of 15 years of industry experience (10 years for Master's degree).
• Must have very strong cell culture techniques with good understanding of cell behavior and cell biology to be able to independently determine health and performance of cells that are used in critical assays.
• Extensive experience in optimizing, executing and managing bioassay performed in 96well plate setting such as imaging-based assays, ELISA and luminescence/fluorescent-based assay.
• Proven ability to design experiments using appropriate standards, controls and assay layout and to troubleshoot as needed.
• Broad experiences in cellular, biochemical and molecular biological methods including but not limited to immunostaining, flow cytometry, protein gel, Western blot, PCR and qPCR.
• Working knowledge in DOE and JMP software is a significant plus.
• Basic understanding of regulatory agency guidance such as FDA, ICH and EMA and hand-on experience is a plus.
• Enjoy learning and challenges. Especially, must be able to learn new instruments and master their software quickly.
• Ability to work in a fast-paced small but growing team environment and to prioritize work from multiple projects. Must be highly reliable and goals/deadlines oriented.
• Must have exceptional written and verbal communication skills to operate in an environment with many moving parts and diverse collaborators.
• Must possess excellent organization skills to be able to manage several projects in parallel.

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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