Project Manager, External Manufacturing

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 Project Manager 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

• Supply: Supports strategic goal to deliver multiple blockbuster rare disease launches by managing scale-up strategy and implementation for new product introductions to CMO partners. Leverages AveXis' scalable manufacturing platform to support IND-enabling clinical program timelines. Ensures efficient, reliable and cost-effective agreements.
• Works closely with external manufacturing partners (i.e Plasmid suppliers) to develop project plans, risk mitigation strategies and timelines/milestones.
• Understands current and future external Clinical supply needs and maximizes supplier utilization to short- and long-term demand.
• Manages contractual obligations advising collaboration participants on how the partnership contract should be implemented.
• Tracks progress, including coordinating the definition and reporting of the KPIs, as well as leading periodic health checks (e.g. Steering committee meetings).
• Manages process by ensuring smooth operation of external collaborations, such as project team meetings, data exchange, and other kinds of interactions.
• Supports efforts to increase alignment and mutual understanding between collaboration participants.
• Interfaces with functional group leaders including Engineering, Manufacturing, Quality Control, Quality Assurance, and Supply Chain to ensure aligned strategies and timelines.
• Manages project meeting content, project objectives and progress to ensure adherence to project plans.
• Supports the PMO group for any technology transfer activities.
• Owns manufacturing process related change controls.
• Reports on project progress identifying issues and risks and offering viable solutions and opportunities as they arise.
• Leads meetings with workstream leaders and sets expectations for project teams.

Qualifications

• Bachelor's degree and 10 years of relevant experience.
• PMP certification desired.
• 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.
• The incumbent must have strong interpersonal skills.

Approximately 50% 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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