Senior Project Manager - Capital Projects

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Jan 04, 2019
Ref
2019-2855
Hotbed
Bio NC
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.

This position is responsible for providing project management to the capital projects group in support of the capitol portfolio. This individual shall have an expert understanding of cGMP Manufacturing and experience providing project leadership and oversight in a highly regulated or pharmaceutical and/or biotech facility. Manages projects in an effective and efficient manner by ensuring delivery for assigned projects. Manages changes such as project expansion, change of scope and schedule, or budget and reports them with impact analysis. Serves as the primary client contact for assigned projects. Manages all contractors and internal staff on projects. Prepares, reviews, and approves scopes or work and proposals. Manages all associated client project deliverables in line with the defined responsibilities of each project team member.

Responsibilities

  • Manages an appropriate number of active projects with regular monitoring and support from upper management, ensuring all assigned projects are delivered on time and within the budget.
  • Leads the team to resolve all project issues and resource constraints affecting the portfolio with assistance from upper management.
  • Manages planning and scheduling conflicts among the project team and with production.
  • Manages client expectations efficiently with minimal guidance. Maintains strong working relationships with all client representatives.
  • Develops project objectives working with user requirement and business plans
  • Prepares, owns, and maintains project budgets
  • Reports on project performance for site leadership
  • Communicates issues or risks in a timely and effective manner and develops mitigation plans to address/resolve them
  • Prepare contingency plans and logically work through complex issues
  • Prepare vendor scopes of work (SOW) and request for proposals (RFP)
  • Work with suppliers and vendors for projects to review and receive quotes
  • Ensures all project close-out activities are completed.
  • Identifies and reports on lessons learned after the project close-out
  • Drive operational excellence and continuous improvement


Qualifications

  • Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience
  • A minimum of 6 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish
  • Experience in the development, automation, and manufacture of gene therapy products, biotech or pharmaceutical products, medical devices, instruments, or biotechnology
  • Experience in process layouts, production layouts and capital improvement projects
  • In-depth knowledge of FDA regulations and GMP systems
  • Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high quality processes and end products
  • Excellent oral and written communication skills. Strong technical writing ability required


Approximately 10-20% travel required

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.