Senior Engineer, Manufacturing Science and Technology- Drug Product (Multiple Openings)

Employer
AveXis Inc.
Location
Libertyville | US-NC-Durham, IL, US
Posted
Sep 08, 2019
Ref
2019-3816
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
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 Senior Engineer is responsible for leading process development and improvement activities for the Drug Product/Fill-Finish manufacturing processes used to manufacture AveXis gene therapy products. This individual will define and direct the activity with internal and external organizations to plan, execute, and document early manufacturing that define the product and process of new AveXis gene therapy candidates. This individual will be responsible for the collection and interpretation of data and collaboration with other departments on manufacturing and product compatibility related issues to drive resolution and process improvements. The Senior Engineer will perform development experiments and oversee the data and reports to support regulatory applications.

Responsibilities

  • Serve as a key scientific and technical lead for Drug Product/Fill-Finish processes at internal and external manufacturing facilities.
  • Partner with Manufacturing and Quality to meet the production schedule, ensure clinical/commercial supply and uphold quality standards.
  • Provide technical/scientific support in process development and qualification efforts for clinical and commercial launch, i.e. material compatibility studies, product stability, process and shipping qualification, etc.
  • Support regulatory applications as subject matter expert for Drug Product/Fill-Finish operations and process development experiments.
  • Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Seek operational excellence and continuous improvement opportunities and implement potential process improvements in conjunction with operations.
  • Support tech transfer and start-up efforts of new products and equipment into GMP manufacturing.
  • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
  • 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 OR
    M.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 3 years of experience in support of biopharmaceutical manufacturing OR
    B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 5 years of experience in support of biopharmaceutical manufacturing.
  • Excellent oral and written communication skills.
  • 5-10 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in sterile filtration and aseptic fill-finish.
  • Familiar with global regulations on devices, drugs, validation/qualification requirements.
  • Strong technical writing ability.
  • Proven ability to effectively lead and participate on teams.

Up to 50% 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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