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Project Manager, Technical Operations and Engineering (GEP)

Employer
Novartis Gene Therapies
Location
Libertyville, IL, US
Start date
Jul 20, 2019

View more

Discipline
Manufacturing & Production, Operations
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest
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 in Global Engineering Projects (GEP) is responsible for delivering projects in the GEP network in support of the global capitol portfolio. As part of the GEP team, this position will be based in our Libertyville facility, but assignments may be located at other network sites in California, Colorado or North Carolina.

This individual shall understand cGMPs and have experience managing projects in a highly regulated pharmaceutical or biotech facility. The Project Manager serves as the primary client contact for assigned projects. The Project Manager is responsible for establishing and maintaining project scope, deliverables, schedules, budgets, reports, and elevating roadblocks. The Project Manager will manage the project team and request resources as required.

Responsibilities

  • Manages small to medium projects ($0.5 - 5 M); projects of staff and contractor teams (2-5 people).
  • Ensures all assigned projects are delivered on time and within the budget.
  • Ensures all projects are executed in accordance with Global standards.
  • 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.
  • Communicates issues or risks in a timely and effective manner and develops mitigation plans to address/resolve them.
  • Prepares vendor scopes of work 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.
  • Provides technical leadership for multiple engineering projects simultaneously.
  • Drives 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 AND
  • A minimum of 5 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in facility build, equipment procurement, capital budget management, and asset lifecycle management.
  • Experience with cGMP construction for brownfield and facility renovations.
  • 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.


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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