Senior Manager, Clinical Supply Chain (Multiple Openings)

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Apr 20, 2019
Ref
2019-3168
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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.

This position is responsible for managing manufacturing and supply chain related activities to support multiple clinical trials associated with multiple programs.

This Senior Manager will provide cross-functional leadership in the development of supply and inventory management plans specific to clinical trial demand that are fully aligned with the global supply plan. This individual will manage the various Contract Manufacturing Organizations (CMO's) that are utilized in the storage and distribution of clinical trial material in the United States (US), European Union (EU) and Rest of World (ROW). As the responsible person for clinical trial packaging and distribution, this individual will also be responsible for all shipping and logistics (domestic and international) to ensure that high quality medicine is delivered in a timely and compliant manner to both clinical and commercial end users.

Responsibilities

  • Manage all required activities performed by the CMO to ensure clinical trial material is packaged and QP/QA released in advance of clinical trial enrollment; manage multiple trails and/or programs.
  • Partner with Clinical Operations to support the clinical trial application and approval process, Pharmacy Manual creation, Site Activation training material, and other activities as needed and related to Manufacturing and Supply Chain.
  • Ensure all required processes and procedures are in place to support distribution from Libertyville to the CMO or commercial end user.
  • 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.
  • Responsible for proactively communicating status, issues and actions to senior management.


Qualifications

  • Minimum B.S. degree in engineering/science, supply chain management, or equivalent.
  • A minimum of 5 -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)
  • Managing vendor/CMO relationships
  • Creating and monitoring local and global supply plans, for both clinical and commercial applications is a plus
  • Strong experience with supply chain methodologies, project management systems and other planning tools.
  • Detailed knowledge of contracting process and associated regulations.
  • 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.
  • Hands on experience supporting inspections with regulatory agencies plus working knowledge of the CFRs and cGMPs related to the above supply chain related responsibilities.

Approximately 10-25% 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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