Manager, External Manufacturing Support

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Oct 10, 2019
Ref
2019-4322
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.

AveXis is seeking a Manager, External Manufacturing Support to provide support to Clinical and External Manufacturing Partners. Must be highly motivated, organized, solution-oriented, and efficient with strong technical aptitude and the ability to work effectively with multiple team members. This will be a fast-paced role within a cross functional project team.

Responsibilities

  • Acts as business alliance manager by ensuring smooth operation of external collaborations, such as project team meetings, data exchange, and other interactions.
  • Works closely with external manufacturing partners (i.e., plasmid suppliers, drug substance manufacturers) to develop project plans, risk mitigation strategies and timelines/milestones.
  • Understands current and future clinical and/or commercial supply needs and maximizes supplier utilization to align with short- and long-term demand.
  • Manages contractual obligations advising collaboration participants on how the partnership contract should be implemented.
  • Supports efforts to increase alignment and mutual understanding between collaboration participant.
  • Interfaces with functional group leaders including Engineering, Manufacturing, Quality Control, Quality Assurance, and Supply Chain to ensure aligned strategies and timelines.
  • Manages coordination of materials, information, documents, change controls with external partners
  • Lead matrix teams to drive technology transfers, process improvements, validation activities, change management, or regulatory submission reviews.
  • Identifies and implements continuous improvement opportunities for process and production related items.
  • Manages and reports on project objectives and progress, identifying issues and risks and offering viable solutions and opportunities as they arise.


Qualifications

  • Bachelor's degree required.
  • 7 years of relevant experience, including experience in GMP manufacturing and working with external partners.
  • Proven ability to manage multiple high-level parallel tasks effectively using technology (i.e. MS Project, Power Point), work unsupervised and possess the ability to apply new techniques using strong prioritization skills.
  • Must display effective planning, organizational, and critical thinking skills, innovativeness, and keen attention to detail and excellent follow through.
  • Strong interpersonal skills and high level of maturity.
  • Approximately 30% travel 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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