Associate Director, Process Engineering

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Dec 05, 2018
Ref
2018-2779
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 Associate Director, Process Engineering will be responsible for leading the process engineering team for our new gene therapy manufacturing facility in RTP. We are seeking an Associate Director to be responsible for leading a team and the lifecycle of GMP process equipment beginning at initial commissioning and qualification. Proven excellence in project management, leadership and communication is required.

Responsibilities

  • Build and develop a Process Engineering team to support our gene therapy plant start up through commercial inventory build and steady state manufacturing operation.
  • Lead discussions with internal business partners on priorities, timelines and sharing of necessary information.
  • Partner with outside vendors and contractors to fulfill business needs.
  • Manage an efficient and effective Process Engineering program through a team of Process Engineers to maintain a reliable and compliant site.
  • Support timely closure of Process Engineering related cGMP deficiencies including audit observations, corrective and preventative actions (CAPA) and deviations.
  • Participate in establishing KPIs including staying on budget, and ensuring staff supports and meets KPIs. Takes corrective actions to mitigate performance gaps.
  • Lead and manage scope of capital projects to upgrade or expand facilities and equipment capability. Manage planning, execution and documentation.
  • Provide necessary guidance to ensure compliance with all applicable external and internal regulations and requirements regarding quality and EHS in the scope of Process Engineering Systems.
  • Drive continuous improvement to meet world class manufacturing standards using operational excellence principles while continuously developing Process Engineering infrastructure best practices.
  • Hire, train and oversee qualified professionals to provide Process Engineering and GMP network services for multiple sites in the Manufacturing organization.


Qualifications

  • Bachelor's degree in Engineering.
  • 15+ years of experience in a biotechnology, gene therapy or pharmaceutical industry.
  • 8+ years project management experience.
  • Experience hiring, managing and developing resources in an operating GMP environment.
  • Experience in a manufacturing facility start up preferred.
  • Proven knowledge and experience with risk-based approach to compliant validation and change management for GMP system.
  • Working knowledge of GEP (Good Engineering Practices).
  • Proven knowledge of both clinical and commercial manufacturing.
  • Proven ability to manage Capital and Operational expenses.
  • Knowledge of the current pharmaceutical, regulatory and technology trends preferred.


Approximately 10% travel required, may require extensive (75%) travel within the first 6 months.

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.