BioProcess Engineer I (Upstream)
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 BioProcess Engineer I is responsible for assisting with organizing, running, and sustaining the manufacturing operations process at the plant/site during off hours. This individual will work on the manufacturing floor to produce product, media/buffer preparation, learn to troubleshoot equipment, participate in interviews on deviations, stocking of items in supply/ production / warehouse area, standardizing equipment and cleaning production area.
- Assist in manufacturing led investigations through partnerships with Quality and other business units at the site.
- Assist BPEs to determine root cause, implement a solution and a verification check to ensure the fix was effective.
- Assist with creation and on-going maintenance of all pertinent equipment, policies, and procedures.
- Be flexible in rotations between upstream and downstream to learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish.
- Assist in producing 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. Learn cGMP and cGDP and 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, CFR's, and internal company policies directly related to the manufacturing process.
- Partner with Quality to ensure a quality and compliant manufacturing environment.
- Assist the technical operations team to resolve any issues related to production.
- 0-2 years' experience in GMP environment with Bachelors of Science Degree in Biology, Chemistry, Biotechnology or applicable field or equivalent experience.
- Excellent oral and written communication skills.
- Entry level into the biopharmaceutical based GMP manufacturing operations, no experience necessary.
- Approximately 10% travel required.
- Must be able to routinely lift over 35 lbs. Must be able to work alternate 12 hour shifts and weekends, as needed.
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.