Senior Project Manager, Global Manufacturing Operations

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Sep 29, 2018
Ref
2018-2587
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. 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 Senior Project Manager, Manufacturing represents operations as a key member of AveXis' program team and launch readiness review teams. This person will work cross-functionally to ensure all aspects of operations are considered as part of the product development, commercialization and launch plans. This will include working closely with members of the regulatory, clinical, quality, medical, and commercial teams, as well as managing critical external partnerships. This person will also drive project management supporting manufacturing and supply chain activities required to successfully launch assigned product and will be responsible for communicating project status, issues, assessing risks, and proposing solutions to the team.

Responsibilities

  • Management of timelines and deliverables of tech transfer, process development, and other projects executed at CMOs and development partners.
  • Ensure successful deliverables of toxicology, clinical trial, and commercial launch material.
  • Financial responsibility for tracking development projects, ensuring costs and payments are executed accurately.
  • Provide management team with weekly/monthly metrics and progress dashboards reflecting status of all development and manufacturing activities.
  • Highlight and escalate issues along with mitigation options/solutions.
  • Manage other project timelines and tracking as required (CMC/IND/BLA).


Qualifications

  • Minimum B.S. degree in science related field; higher level degree: MS, MBA preferred but not required, PMP Certification preferred but not required.
  • Direct, hands-on experience in manufacturing, quality, and contract supplier/customer interactions.
  • Strong project management, budget, and presentation skills.
  • Ability to synthesize detailed information and provide critical insights across manufacturing and supply chain.
  • Experience working with contract suppliers and customers (ability to build strong relationships and influence positive results).
  • Knowledge and understanding of cGMPs.

This position will be located out of our Chicago or North Carolina area office, with 25-50% travel.

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.