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 leading capital projects in San Diego in support of the AveXis capital portfolio. As part of the GEP team, assignments may be located at other network sites in Illinois or North Carolina. This individual shall have a strong understanding of GMPs and experience providing leadership and oversight in a highly regulated or pharmaceutical/biotech facility. This role will lead projects to design, construct, and qualify development, clinical and commercial laboratories and pilot plants at the San Diego facility as the primary location with additional project support at the other sites as required. Job functions include management of contractors, staff and projects in an effective and efficient manner, assigning project to staff from the approved portfolio, and supporting department improvement initiatives.
Creates and owns global programs in support of the GEP project delivery lifecycle which may include business case development, project execution, and engineering document management.
Leads, develops and maintains a site master plan based on key customer feedback for the overall San Diego Facility.
Leads and manages the annual capital planning effort for the next fiscal year.
Manages resources to ensure that the GEP group is responsive to customer needs.
Provides oversight to all San Diego projects and reports schedule and budget to senior leadership.
Manages client expectations efficiently.
Maintains strong working relationships with all client representatives.
Develops project objectives working with user requirement and business plans.
Prepares, owns, and maintains budgets for the San Diego capital portfolio.
Reports on portfolio performance for GEP and site leadership.
Manages an appropriate number of projects as Project Manager ensuring all assigned projects are delivered on time and within the budget.
Provides technical expertise to internal and external customers.
Occasionally serves as the technical lead on projects.
Communicates issues or risks in a timely and effective manner and develops mitigation plans to address/resolve them.
Prepares contingency plans and logically works through complex issues.
Works 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.
Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience plus a minimum of 15 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in facility design and build, equipment procurement, capital budget management, and asset lifecycle management.
Experience in the development, automation, and manufacture of gene therapy, 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 20-40% 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.