Project Manager -External Manufacturing (Multiple Openings)

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) 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

• Clinical 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.
• Contract management: Manages contractual obligations advising collaboration participants on how the partnership contract should be implemented.
• Progress monitoring: Tracks progress, including coordinating the definition and reporting of the KPIs, as well as leading periodic health checks (e.g. Steering committee meetings).
• Process management: Ensures smooth operation of external collaborations, such as project team meetings, data exchange, and other kinds of interactions.
• Alignment and relationship building: 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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