Internship, Manufacturing Quality and Compliance

Employer
AveXis Inc.
Location
Libertyville, IL, US
Posted
Nov 03, 2018
Ref
2018-2603
Hotbed
BioMidwest
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 Summer Intern will work at an AveXis site on various activities included, but not limited to, on the floor quality support of the manufacturing processes, help drive process improvements, receipt/release of incoming materials, management of site suppliers.

Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Complete requisite training as well as all applicable policies and procedures related to the specific job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time.

Responsibilities

  • Complete on the floor quality audits and sampling during the manufacturing processes.
  • Work effectively with operators on the floor and make on the spot, risk-based decisions; escalate issues to management as necessary.
  • Ensure Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause.
  • Vendor Management/Raw Material Release: Ensure all required assessment is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product.
  • Create monthly Quality Management Review meeting (QMR) to review site metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
  • Provides cGMP observations to management; presents information to employees and management.
  • Ensure cGMP documentation is being filled out correctly, training is current, and all Quality requirements are being followed.
  • Look for opportunities to implement operational excellence and continuous improvement.


Qualifications

  • Enrolled in a 4 year program, or recently completed a bachelor's degree. in biochemistry, chemical engineering, bioengineering, or science related field.
  • Excellent oral and written communication skills.
  • 3.0 GPA


Additional Requirements:

Must be able to routinely lift over 35 lbs.

Other Duties

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.