BioProcess Engineer III (Downstream)
Company: AveXis Inc.
Posted on: June 14, 2019
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 BioProcess 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. Responsibilities
- Produce clinical and commercial material on an annual basis
that meets the site's strategic objectives and is compliant with
- Ensure cGMP documentation is being filled out correctly,
training is current and all Quality requirements are being
- 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
- Support tech transfer of new products and processes to ensure
smooth transition from process development into GMP
- Provide hands on technical leadership to the manufacturing
- Look for opportunities to implement operational excellence and
- Partner with Quality to ensure a quality and compliant
- 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. Qualifications
- 4+ years' experience in Biological Manufacturing
- 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
- Project management skill set with experience in
strategic/tactical planning, team building, and meeting
- 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. #LI-RL1
Keywords: AveXis Inc., Denver , BioProcess Engineer III (Downstream), Engineering , Longmont, Colorado
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