AveXis, Inc. Manufacturing Quality Supervisor in Libertyville, Illinois
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 Manufacturing Quality Supervisor (MQ) will provide critical quality expertise to transition a novel gene therapy into a commercially approved product and is responsible for implementing robust Quality Systems for a new viral gene therapy manufacturing site and being quality on the manufacturing floor.
Deliver a robust overall quality systems, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes.
Quality decision making on the manufacturing floor
SOPs/Document Management: Approve all instruction sets, specifications, batch records etc. and other Quality procedures directly related to operations and other cGMP activities
On the floor Batch record review: Ability to review controlled documentation during processing for GMP and GDP
Deviation/CAPA Management approval: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Requires direct input on the creation and effectiveness of Corrective and Preventive Action plans. Assist with implementation and supporting on-going continuous improvements.
In process sampling/ AQL sampling: Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product
Training: Ensure all personnel, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations
Supervise Manufacturing Quality Associates by providing work direction, performance management and professional development.
Minimum B.S. degree in preferably microbiology, chemistry or biochemistry
A minimum of 3-5 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification and aseptic fill/finish
Experience with viral gene therapies and/or orphan disease indications is a plus
Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections
Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations
Excellent oral and written communication skills with strong technical writing experience required. Experience leading both internal audits, identify findings, drive resolution and provide closure report
Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward
Knowledge of AQLs and visual inspection
Strong knowledge and application of the CFR’s and cGMP’s.
Approximately 10% 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.
External Company URL: https://avexis.com/
Street: 1940 USG Drive