Principal Engineer, Site Manufacturing Science and Technology

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 Principal Engineer/Scientist is responsible for defining and leading development and improvement activities for the manufacturing processes used to manufacture AveXis gene therapy products at teh Durham, NC site. This individual will be responsible for the process related aspects of the downstream process and/or the technical transfer of new drug entities to the Durham site utilizing the platform gene therapy process. In addition, this individual will lead a cross functional teams for downstream process improvements and/or tech transfers to the site while serving as the technical lead.

Responsibilities

• Act 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.
• Mentor and train engineering team members.
• Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
• Define potential process improvements in conjunction with the Global process owners and operations and lead implementation of process changes.
• Participate in start-up efforts of new equipment, software or processes in manufacturing.
• Develop, communicate, and implement strategic planning for business development and future improvements.
• Assist in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
• Provide technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
• Utilize small-scale production processes and scaled-down lab processes to enable process troubleshooting, with the potential to oversee these experiments at external partners.
• Provide leadership for tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
• Identify opportunities to implement operational excellence and continuous improvement.
• Build strong relationships with Quality to ensure a compliant manufacturing environment.
• Assist the technical operations team in resolving any issues related to production.
• Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.

Qualifications

• PhD in biochemistry, chemical engineering, bioengineering, or related technical field and at least 8 years of experience in support of biopharmaceutical manufacturing or
  M.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 10 years of experience in support of biopharmaceutical manufacturing or
  B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing.
• Excellent oral and written communication skills.
• Experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish.
• Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
• Strong technical writing ability.
• Proven ability to effectively lead and participate on teams.
• Leadership of technical staff either directly or in a matrix organization.

Up to 25% travel may be required. Position will be based at Durham, NC site.

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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