Senior Engineer, Process Data Analytics, Manufacturing Science and Technology

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Oct 18, 2018
Ref
2018-2645
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 Senior Engineer, Process Data Analytics is responsible for developing tools and processes for analyzing process data for the manufacturing processes used to manufacture AveXis gene therapy products at the RTP, NC site. This individual will lead the development of process data analysis approach for the commercial and clinical products at the RTP site. In addition, this individual will partner with Manufacturing, Engineering and Quality to define how process data will be collected, stored, analyzed and reported to assure the manufacturing processes stay in control.

Responsibilities

  • Serving as a technical expert for data collection and analysis, this position will assist in defining the methods for the collection and analysis of process, analytical and equipment performance for all products manufactured at AveXis RTP, NC site.
  • Partnering with Quality, Engineering and Manufacturing to define, implement and analyze process data.
  • Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Provide expertise in data analysis and statistics to assure process performance and identify process improvement opportunities.
  • Provide technical leadership as required during start-up efforts of new equipment, software or processes in manufacturing to assure data collection requirements are met.
  • Partner with Quality, Manufacturing to ensure a compliant manufacturing environment.
  • Assist the technical operations team to resolve any issues related to production
  • Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.


Qualifications

  • B.S. degree in biochemistry, engineering, bioengineering, or related technical field and at least 10 years of experience in support of biopharmaceutical manufacturing.
  • Excellent oral and written communication skills.
  • 10+ years of experience in process scientist/engineer roles within a biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish.
  • Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements.
  • Knowledge of data collection and analysis tools and experience with statistical analysis of process data.
  • Strong technical writing ability.
  • Proven ability to effectively lead and participate on teams.

May require some travel.

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.