Engineer, Manufacturing Science and Technology - Plasmid

Employer
AveXis Inc.
Location
Libertyville | US-NC-Durham, IL, US
Posted
Oct 20, 2019
Ref
2019-4225
Hotbed
BioMidwest
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.

AveXis is seeking an Engineer, Manufacturing Science and Technology, Plasmid to compile, monitor, review data to advance the development of plasmids used in AveXis products from research through GMP manufacturing. The Engineer will be responsible for developing a system to compile, analyze, illustrate, and distribute technical process performance data in support of the Technical Development/Manufacturing Science and Technology (MSAT) organization, with emphasis on the upstream and downstream plasmid manufacturing processes as well as analytical methods. This role will be expected to collaborate with site MSAT teams to evaluate cross-site performance (internal and external) and contribute to data analysis and reports to support approval of gene therapy products. This individual must have fundamental knowledge of upstream, downstream, and analytical areas to support the broader team and be able to highlight relevant data through review. The individual will provide support for the process and will also provide analytical and characterization knowledge related to the manufacturing of plasmids utilized to manufacture gene therapy products. The successful candidate will ensure all documentation and reports are accurate, complete, and suitable for use in support of production, characterization, and regulatory approval.

Responsibilities

  • Provide scientific and technical input for process-related issues at internal sites, as well as with external partners.
  • Perform trending and monitoring of critical quality attributes/process parameters to maintain product quality and to control process drift.
  • Monitor cross-site manufacturing process performance to identify key areas of risk and development based on process performance data in the commercial, clinical, and development spaces.
  • Perform statistical analyses to understand normal process variability, support establishment of parameters and criteria, and process comparability assessments.
  • Identify potential process improvements.
  • Assist in documenting changes and updates to manufacturing processes and work with manufacturing, engineering and validation to implement those changes.
  • Review and provide feedback and technical/scientific support on project deliverables (e.g. remediation initiatives, plan reports).
  • Assist manufacturing by supporting investigations in partnerships with External Manufacturing, External Quality, and other business units at the site to determine root cause for variation, implement solutions, and ensure corrective and preventative actions are effective.
  • Participate in the collection and interpretation of data and collaborate with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals.


Qualifications

  • Bachelor's degree in analytical chemistry, biochemistry, chemical engineering, bio-engineering, or related technical field; Master's degree or PhD preferred.
  • Expertise with data collection systems and analysis tools such as the development of Excel macros.
  • 2 to 5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in either recovery, purification, or analytical methods development. General understanding of fermentation.
  • Familiar with global GMP regulations.
  • Excellent communication skills and attention to details.
  • Strong organizational skills and ability to multitask across projects and activities.
  • 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.

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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