Senior Engineer, Manufacturing Science and Technology- Upstream (Gene Therapy)

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 Senior Engineer is responsible for leading development and improvement activities for the drug product manufacturing processes used to manufacture AveXis gene therapy products at a site. This individual will be responsible for the collection and interpretation of process 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 product 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/critical process parameters to maintain product quality and to control process drift.
• Implement potential 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 working 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 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

• Bachelor of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 6 years of experience in support of biopharmaceutical manufacturing OR
• Master of Science degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 4 years of experience in support of biopharmaceutical manufacturing OR
• PhD in biochemistry, chemical engineering, bioengineering, or related technical field.
• Excellent oral and written communication skills.
• Preferred Experience:
  • 5-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in aseptic fill/finish, additional experience in cell culture, recovery, or purification .
  • Familiar with global regulations on devices, drugs, validation/qualification requirements.
  • Strong technical writing ability.
  • Proven ability to effectively lead and participate on teams.
• May travel up to 10% - 15%.

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-JH1