DurhamRecruiter Since 2001
the smart solution for Durham jobs

Scientist, Technical Development – Downstream

Company: AveXis Inc.
Location: Durham
Posted on: September 15, 2019

Job Description:

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 (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 Scientist is responsible for contributing to the development of the downstream manufacturing platform and generating/compiling data and reports to support approval of AveXis gene therapy products. This role will support activity with internal and external organizations to plan, execute, and document experiments that define the process and transfer of the process to the clinical and commercial sites. The Scientist will provide support for process, analytical, and characterization knowledge related to the production of AveXis gene therapy products, and the raw materials needed to make them. Responsibilities of primary importance are to support the completion of time-sensitive studies and validation at internal and external partners while capturing related data and knowledge, to advance the development of AveXis products from research and development to GMP manufacturing. Responsibilities Support Downstream Process Owner team on process-related issues at internal AveXis sites, as well as with external partners. Support trending and monitoring of critical quality attributes/ process parameters to maintain product quality and to control process drift. Assist in identifying and implementing potential process improvements in conjunction with manufacturing operations. Assist in start-up efforts of new equipment, software or processes in manufacturing. Author and support documentation of changes/updates to manufacturing processes. Review and provide feedback and technical/scientific support on project deliverables (e.g. remediation initiatives, plan reports, etc.). Support investigations in partnership with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective. Participate in the collection and interpretation of data, and collaboration with other departments on manufacturing related issues to support issue resolution. Contribute to the downstream portion of the platform processes, planning to avoid delays, and supporting the activity and team to deliver a robust and effective product and manufacturing process. Complete requisite training on all applicable policies and procedures related to the job function. Qualifications Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, Master's degree or PhD preferred. Excellent oral and written communication skills; demonstrated technical writing. 4-6 years of experience in biopharmaceutical based GMP manufacturing operations and/or process development. Experience with filtration, chromatography, and purification technologies. Experience with data analysis/interpretation to progress development strategies. Working knowledge in DOE and/or statistics is a plus. Approximately 10% to 25% travel may be 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. #LI-JH1

Keywords: AveXis Inc., Durham , Scientist, Technical Development – Downstream, Other , Durham, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


CDL-A Owner Operator Truck Driver
Description: FLATBED CDL-A INDEPENDENT CONTRACTOR TRUCK DRIVER JOBS 8K Elite Bonus For Independent Contractors At Boyd Bros. At Boyd Bros., we are
Company: Boyd Bros Transportation
Location: Rocky Mount
Posted on: 09/16/2019

CDL-A Owner Operator Truck Driver
Description: FLATBED CDL-A INDEPENDENT CONTRACTOR TRUCK DRIVER JOBS 8K Elite Bonus For Independent Contractors At Boyd Bros. At Boyd Bros., we are
Company: Boyd Bros Transportation
Location: Danville
Posted on: 09/16/2019

Virtual Customer Service Manager-French Bilingual
Description: Exciting opportunity for a seasoned manager to come in and help build our virtual French Bilingual team Mommy Jobs Online mommyjobsonline.com is looking for the right candidate that has experience (more...)
Company: mommy jobs online
Location: Danville
Posted on: 09/16/2019


Seasonal Store Associate/Stocker - 5183
Description: Description br br Performs general store operational duties including cashiering, customer service, truck unloading, stocking, merchandise recovery, and light cleaning or maintenance as assigned. (more...)
Company: Big Lots
Location: Wilson
Posted on: 09/16/2019

Information Technology Specialist (25B)
Description: 25B Information Technology Specialist Job ID: 1108986 Job Views: 103 Location: DANVILLE, Virginia, United States ZIP Code: 24540 Job Category: Technology and Networking Posted: 09.04.2019 Age Requirements: (more...)
Company: Army National Guard
Location: Danville
Posted on: 09/16/2019

HR Personnel Assistant - Work From Home
Description: Job Duties: You will need to make outbound calls to jobseekers pertaining to joining our remote work-at-home job board to find employment. You will need to post classified job ads on a daily basis of (more...)
Company: Mommy Jobs Online
Location: Danville
Posted on: 09/16/2019

Truck Driver (88M)
Description: 88M Truck Driver Job ID: 1108989 Job Views: 98 Location: DANVILLE, Virginia, United States ZIP Code: 24540 Job Category: Transport Posted: 09.04.2019 Age Requirements: Must be between the ages (more...)
Company: Army National Guard
Location: Danville
Posted on: 09/16/2019

Graduates - Teach English In China. Free Flights
Description: About EF English First EF English First is the world's leading privately owned education company. Founded in 1965, EF operates in over 50 countries around the world. We have vacancies for english teaching (more...)
Company: EF English First
Location: Rocky Mount
Posted on: 09/16/2019

Work at Home Benefit Specialist Hiring NOW !!
Description: Are You Motivated Be part of the Largest Health Benefits Discount company in the nation and assist people to
Company: MAH Benefits
Location: Chapel Hill
Posted on: 09/16/2019

ESL Teacher Jobs In China - 60 Cities. BA/BSc Req.
Description: About EF English First EF English First is the world's leading privately owned education company. Founded in 1965, EF operates in over 50 countries around the world. We have vacancies for english teaching (more...)
Company: EF English First
Location: Rocky Mount
Posted on: 09/16/2019

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Durham RSS job feeds