Project Manager, Analytical/Quality Control (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 support Manufacturing and Supply Chain by engaging internal and external teams to deliver analytical and quality control projects for preclinical and clinical phase programs. This will be a fast-paced role, responsible for developing, maintaining, and reporting timelines, while managing forecasts and other analytical activities. The ideal candidate will be highly motivated, organized, solution-oriented, enthusiastic and ready to hit the ground running.

Responsibilities

• Supports Manufacturing and Supply Chain by driving analytical and QC deliverables to support IND activities and late phase clinical projects.
• Facilitates high level workflow via program forecasting, and is responsible for developing, maintaining, tracking and reporting timelines.
• Main point of contact for partner CROs and CMOs, maintains vendor relationships, and manages vendor RFPs, proposals, contracts, and purchase orders.
• Leads meetings, manages project meeting content, project objectives and progress, with organized minutes and action tracking.
• Drives method development, transfer, optimization, or other analytical activities.
• Interfaces with Analytical, QC, and Sample Management leadership, as well as other functional leaders, to guarantee aligned strategies and timelines.
• Ensures that POs and invoices are maintained, and monitors QC and analytical budgets.
• Reports on project progress, identifying issues/risks and offering risk mitigation and viable solutions as they arise.
• Manages project scope and engages SME support as needed to ensure alignment is in place for all QC team projects.
• Motivates the team and creates a positive, collaborative environment that results in timely deliverables and overall team success.

Qualifications

• Minimum B.A. or B.S. in a scientific discipline, preferably in biochemistry or related field.
• Minimum of 3-5 years of experience working in a GMP QC or analytical development laboratory required, experience in QC method and tech transfer preferred.
• Proven ability to manage multiple high-level parallel tasks effectively using technology - must have strong MS project, excel, and PowerPoint skills.
• The ideal candidate is enthusiastic and engaging; excellent communication and interpersonal skills are must.
• Prior PM experience is preferred but not required.
• Desire and ability to work in a fast-paced, dynamic environment.

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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