Associate Director, Supply Chain, Commercial Launch - Libertyville , Illinois, United States, 60048
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.
This position is responsible for managing launch readiness as it relates to order handing, secondary packaging and distribution readiness with the US and ex-US countries as applicable.
The Associate Director will be responsible for managing secondary packaging vendor relationships and enduring secondary packaging materials are ready in support of program commercialization timelines. As the key leader for the Manufacturing and Supply Chain team distribution activities, this individual will also be responsible for setting up all shipping and logistics for commercial distribution to ensure that high quality medicine is delivered in a timely and compliant manner to end users. This role is also responsible for setting up and supporting distribution for Early Access Programs globally from Libertyville, Illinois.
- Ensure all required processes and procedures are in place to support distribution from the site to the commercial end user.
- Support US commercialization process creation and execution for all AveXis manufactured products.
- Work cross functionally with Commercial, Marketing, Regulatory and Quality to create secondary packaging in support of commercial launch for each product/program.
- Meet or exceed all Quality System requirements for pertinent area of management.
- Support regulatory inspections from a warehouse, storage, facility, and cold chain perspective for launch readiness.
- Responsible for proactively communicating status, issues and actions to senior management.
- Financial responsibility for all US/ex-US launch supply chain related spend.
- Minimum B.S. degree in engineering/science, supply chain management, or equivalent.
- A minimum of 7-10 years of direct experience in complex, multi-product high quality biopharmaceutical manufacturing and/or supply chain including:
- Managing logistics for temperature sensitive shipments (domestic and international).
- Creating and monitoring local and global supply plans, for clinical and/or commercial applications is a plus.
- Strong experience with supply chain methodologies, project management systems and other planning tools.
- Strong teamwork and interpersonal skills.
- Ability to work effectively across different functions within the organization and externally with critical vendors and suppliers.
- Detailed experience and knowledge of organizational structure, workflow and operating procedures.
- Strong knowledge of accounting/financial/business analysis processes and techniques.
- Hands on experience supporting inspections with regulatory agencies plus working knowledge of the CFRs and cGMPs related to the above supply chain related responsibilities.
- Travel may be 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.