Process Engineer - cGMP Gene Therapy Manufacturing

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 Process Engineer is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at the manufacturing site. Equipment may include major processing equipment such as bioreactors, tangential flow filtration, chromatography, filling equipment, support systems such as incubators, freezers biosafety cabinets, offline benchtop instruments or facility/utility systems. This individual will be required to develop an understanding of current and future processes and translate these into the facility and equipment requirements at the manufacturing site.

Responsibilities

• Ensuring new equipment is appropriately designed/qualified and existing processes runs in a compliant manner through equipment lifecycle. To include:
• Investigating any equipment or process deviations.
• Developing corrective actions to prevent reoccurrences.
• Appropriate change management for any changes to qualified systems.
• Owns and manages changes to the process equipment to maintain equipment in a validated state.
• Problem solve any technically related issues impacting production.
• Develop and implement equipment reliability and maintenance strategies that are compliant, effective and cost appropriate.
• Routinely monitor equipment performance.
• Develops project objectives working with user requirement and business plans.
• Determines project specifications and appropriate technology's to be implemented.
• Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).
• Support investigation non-conformances associates with equipment, facility or utility systems.
• Participate in all FDA and internal audits of the manufacturing facilities and process equipment and respond to any observations received.
• Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to equipment systems.
• Represent process engineering and validation in any technology transfer activities.
• Responsible for either leading or providing SME support on capital related projects.

Qualifications

• Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, and 4 years of equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• Experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology.
• In-depth knowledge of FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
• 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.
• Travel as required to other internal sites, vendors, and CMOs as required (~20%).

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.