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Job Details

Principal Engineer Manufacturing Science and Technology Upstream and Downstream Lab

Location
Longmont, CO, United States

Posted on
May 08, 2020

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Profile

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 Principle Engineer, Manufacturing Science and Technology is responsible for defining and leading development and improvement activities for the Upstream manufacturing processes used to manufacture AveXis gene therapy products. This individual will also be responsible for the collection and interpretation of data in collaboration with team members and other departments to produce reports that serve to describe the manufacturing process.

Responsibilities

  • Serve as a scientific and technical lead in support of investigations and process development activities.
  • Perform laboratory experiments to determine critical quality attributes/critical process parameters to deliver a robust manufacturing process with focus on product quality.
  • Define and lead implementation of potential process improvements in conjunction with the global process owners and operations.
  • Contribute to the advancement and implementation of cell culture and transfection technologies used in the production of gene therapy products.
  • Utilize small-scale production processes and scaled-down models to enable process troubleshooting and characterization.
  • Completion of requisite training and applicable policies and procedures, related to the job function.


Qualifications

  • PhD in molecular biology, biochemistry, chemical engineering, bioengineering, or a related technical field and at least 8 years of experience in support of biopharmaceutical research and development OR
    M.S. degree in molecular biology, biochemistry, chemical engineering, bioengineering, or a related technical field and at least 10 years of experience in support of biopharmaceutical research and development OR
    B.S. degree in molecular biology, biochemistry, chemical engineering, bioengineering, or a related technical field and at least 12 years of experience in support of biopharmaceutical research and development.
  • Excellent oral and written communication skills.
  • 8 years of industry experience in cell culture based vaccine or viral vector production with emphasis in research and development.
  • Ability to effectively design experiments, analyze and interpret data to progress development strategies.
  • Familiar with global regulations on cGMP manufacturing of drug substance, drug product devices, validation/qualification requirements preferred.
  • Leadership experience of technical staff either directly or in a matrix organization preferred.


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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