Senior Scientist, Technical Development - Drug Product

Location
Durham, NC, US
Posted
Nov 21, 2020
Ref
5222
Hotbed
Bio NC
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 Senior Scientist is responsible for leading the development and improvement of the Drug Product/Fill-Finish manufacturing processes used to manufacture AveXis gene therapy products. This individual will lead and support activity with internal and external organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. The Senior Scientist will provide leadership and support for process, analytical, an characterization knowledge related to the production of AveXis gene therapy products, and the raw materials needed to make them.

Responsibilities of primary importance are to ensure the execution of time-sensitive experiments, studies, and validation at external partners while capturing related data and knowledge, to advance the development of AveXis products from Research to Development, and on to GMP manufacturing. This role will ensure all documentation and reports are accurate, complete, and suitable for using in support of production, characterization, and regulatory approval of AveXis products.

Responsibilities
  • Provide scientific and technical input for Drug Product/Fill-Finish process-related issues at internal AveXis sites, as well as with external partners.
  • Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Identify and implement potential process improvements in conjunction with manufacturing operations.
  • Provide technical/scientific support in process development and qualification efforts for clinical and commercial launch, i.e. formulation development, in-use compatibility studies, product stability, process and shipping qualification, etc.
  • Support tech transfer and participate in start-up efforts of new products, 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.
  • Support regulatory applications as subject matter expert for Drug Product/Fill-Finish operations and process development experiments.
  • Participate in leading investigations in partnerships with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective.
  • Participate in the collection and interpretation of data, and collaboration with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals.

Qualifications
  • Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, Master's degree or PhD preferred.
  • Excellent oral and written communication skills.
  • Minimum 6 years of experience (with a Bachelor's degree) in biopharmaceutical based GMP manufacturing operations including direct experience in sterile filtration and aseptic fill-finish.
  • Familiar with global regulations on drug product and validation/qualification requirements.
  • Ability to effectively and efficiently analyze and interpret data to further progress development strategies.
  • Approximately 10% 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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