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 (ZOLGENSMA). 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 Science Engineer III is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.
Design and conduct experiments supporting the development and implementation of a closed system, scale-up, recovery, and purification processes for gene therapy.
Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.
Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions and recommending options for future experiments to achieve project goals.
Produce pre-clinical and clinical material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
Appropriately document experimental procedures and results according to established guidelines. For cGMP manufacturing, ensure documentation is being filled out correctly, training is current, and all Quality requirements are being followed.
Participate in tours or information requests for all FDA and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.
Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies related to the manufacturing process.
Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing.
Provide hands on technical leadership to the manufacturing staff members.
Look for opportunities to implement operational excellence and continuous improvement.
Partner with Quality to ensure a quality and compliant manufacturing environment.
Support Director of Operations to meet information requirements as needed for quality, compliance, and management reporting.
Assist the technical operations team to resolve any issues related to production.
Adhere to all EH&S policies, procedures and guidelines.
4+ years' experience in Biological Manufacturing environment.
A minimum of 4-7 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish with working knowledge of FDA regulations and GMP systems.
Excellent oral and written communication skills. Strong technical writing ability required.
Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence.
Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing).
Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.
Approximately 10% travel required.
Must be able to routinely lift over 35 lbs.
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.