Senior Engineer, Manufacturing Science and Technology (Upstream)

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. 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.

The Senior Engineer (Upstream) is responsible for leading development and improvement activities of the upstream manufacturing processes used to manufacture AveXis gene therapy products. This individual will be responsible for the collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements.

Responsibilities

• Serve as a scientific and technical lead for process-related issues and investigations at the facility.
• Partner with manufacturing to meet the production schedule, ensure commercial supply and uphold quality standards.
• Perform trending and monitoring of critical quality attributes/process parameters to maintain product quality and control process drift.
• Implement process improvements in conjunction with operations.
• Participate in start-up efforts of new equipment, software or processes in manufacturing.
• Assist in documenting changes/updates to manufacturing processes and partner with manufacturing, engineering and validation to implement those changes.
• Provide technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports.
• Utilize small-scale production processes and scaled-down lab processes to enable process troubleshooting, with the potential to oversee these experiments at external partners.
• Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
• Look for opportunities to implement operational excellence and continuous improvement.
• Partner with Quality to ensure a compliant manufacturing environment.
• Assist the technical operations team to resolve issues related to production.
• Complete requisite training and understand applicable policies and procedures, related to the job function to support ongoing manufacturing support.

Qualifications

• PhD in biochemistry, chemical engineering, bioengineering, or related technical field or Master's degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 4 years of experience in support of biopharmaceutical manufacturing or Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 2 years of experience in support of biopharmaceutical manufacturing
• Excellent oral and written communication skills.
• 5-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture and recovery to support drug substance production.
• Familiar with global regulations on devices, drugs, validation/qualification requirements.
• Strong technical writing ability.
• Proven ability to effectively lead and participate on teams.

Up 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.