Ready to join a team committed to moving gene therapies into the clinical setting 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 at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.
AveXis, Inc. 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 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 BioProcess Engineer is responsible 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, help drive process improvements, error proof the process, investigate deviations, and provide ownership for specific pieces of processing equipment.
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 and ensure all members of the manufacturing team are current in their training requirements as well as all applicable policies and procedures related to the job function. The successful candidate will take accountability to ensure all documentation is complete and accurate, so issues can be addressed real time.
Other responsibilities include providing assistance in manufacturing led investigations through partnerships with Quality and other business units at the site. Work to determine root cause, implement a solution and a verification check to ensure the fix was effective. Participate in the interpretation of data and collaboration with other departments on all manufacturing related issues to drive resolution and process improvements. Assist with creation and on-going maintenance of all pertinent equipment, policies, and procedures.
The BioProcess Engineer will be responsible for owning the process, planning ahead to avoid delays, and good documentation practices. Participate in continuous improvement and operational excellence projects to help drive efficiency, while error proofing the process.
• Produce clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs
• Support the product requirements to ensure that all products are produced according to plan.
• Ensure cGMP 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.
• Responsible for maintaining quality standards to meet cGMP requirements, CFR’s, and internal company policies directly related to the manufacturing process
• Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing
• Look for opportunities to implement operational excellence and continuous improvement
• Partner with Quality to ensure a quality and compliant manufacturing environment
• Assist the technical operations team to resolve any issues related to production.
• Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience
• Excellent oral and written communication skills.
• 0-2 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish
• Working knowledge of FDA regulations and GMP systems
• Strong technical writing ability
• Proven ability to effectively lead and participate on teams.
Additional Requirements: Approximately 10% travel required Must be able to routinely lift over 35 lbs.
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.