Associate Director, Global Packaging Technology

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.

The Associate Director, Global Packaging Technology is responsible for end-to-end packaging supply chain activities for Commercial and Clinical supply. They will be accountable for design, development, and qualification of secondary and tertiary packaging systems, driving simplification and supply optimization in response to all business drivers. The individual is chartered with enabling packaging supply chain security and the brand protection strategy and road map. This individual will play a key role within Global Supply Chain, assisting with vision setting and development of new packaging technology capability.

Responsibilities

• Design, develop, and qualify secondary and tertiary Clinical and Commercial product packaging (i.e. cold chain bulk and finish goods) focused on identifying opportunities to optimize cost, service and quality (i.e. print-on-line technology to leverage Late Stage Packaging supply).
• Establishes Clinical and Commercial packaging supply chain systems and processes based upon key business drivers: compliance and risk management, process rationalization, supply performance, etc.
• Actively supports root cause analysis for Clinical and Commercial packaging related quality investigations
• Collaborate with MS&T with primary pack design and selection ensuring supply robustness.
• Lead artwork labeling design and development for Clinical programs and supply.
• Actively supports technical impact assessments for secondary and tertiary packaging systems.
• Establishes packaging supply chain security and brand protection strategy and road map
• Partners with regional Supply Chain leads to understand current and proposed packaging related market requirements and how to best influence and advocate for robust supply solutions (i.e. Serialization, Child Resistance, Tamper Evidence).
• Build strong cross-functional relationships and provide global packaging technology leadership and vision for ensuring robust, effective, and efficient Clinical and Commercial supply.

Qualifications

• Bachelor's degree in Business or technical field and Master of Business Administration (MBA).
• Minimum of 7 years of experience in pharmaceutical and biotech Clinical and Commercial packaging supply chain systems.
• Business acumen - knows how to assess market/business requirements and develop appropriate business case justifications that ensure compliance and/or improve supply.
• Experience working in highly regulated industries.
• Experience in a continuous improvement environment with a track record of achieving results.
• Demonstrated collaborative style in performing sourcing activities.
• Influences without authority to motivate and manage a cross-functional team in multiple geographies.
• Hands-on manufacturing and/or supply chain experience.

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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