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Manufacturing Associate/Bio Process Summer Intern

Avexis, Inc

Manufacturing Associate/Bio Process Summer Intern

Durham, NC
Internship
Paid
  • Responsibilities

    Manufacturing Associate/Bio Process Summer Intern - Durham Job Locations US-NC-Durham Posted Date 2 days ago (10/15/2018 3:29 PM) Job ID 2018-2620 # of Openings 1 Category Manufacturing Overview 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 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, produce product, troubleshoot and/or validate equipment, help drive process improvements, help investigate deviations, provide market and other strategic analysis, and/or work with supply chain vendors. 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 Project based scope could include manufacturing operations, documentation support, continuous improvement, and/or technology implementation. 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. Responsible for maintaining quality standards to meet cGMP requirements, CFRs, 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. Qualifications Enrolled in a 4 year program, or recently completed a bachelors degree in biochemistry, chemical engineering, bioengineering or life sciences. Excellent oral and written communication skills. Experience in leading projects. 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. 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.

  • Industry
    Manufacturing