Engineer, Manufacturing Science and Technology

Employer
AveXis Inc.
Location
Longmont, CO, US
Posted
Sep 08, 2019
Ref
2019-3871
Required Education
Bachelors Degree
Position Type
Full time
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 Engineer is responsible for assisting with the development and improvement of the manufacturing processes used to manufacture AveXis gene therapy products at the site. This individual will support 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 representative 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/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 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.
  • 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 in resolving issues related to production.


Qualifications

  • Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field.
  • 2-5 years of 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 participate on teams.


Up to 25% travel may be required

The level of this position will be based on the final candidate's qualifications. The position may have Laboratory, Upstream, or Downstream focus.

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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