Manufacturing Specialist - Fill Finish
Company: AveXis Inc.
Posted on: March 27, 2020
OverviewReady 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 Manufacturing Specialist is responsible
to support the primary manufacturing process owner and the
manufacturing group by providing required process input to the
engineering, validation, MSAT, maintenance, QC and QA groups at
both the Durham and Libertyville manufacturing sites. The
Manufacturing Specialist will be the owner of portions of the
manufacturing process supporting the upstream, downstream,
fill/finish, or manufacturing support groups. This individual will
be required to ensure manufacturing process alignments between both
manufacturing sites and may support new product introductions
technology transfers into and out of the manufacturing
- Support the manufacturing process owner (SME) for a portion of
the manufacturing process (upstream, downstream, fill/finish, or
- Ensures process alignment between the manufacturing sites
through collaborative interactions with manufacturing, MSAT, QA/QC,
and the supply chain functions at both production sites.
- Serve as a manufacturing document owner for certain production
- Own critical manufacturing deviation investigations and define
pragmatic and effective CAPAs.
- Identify, develop and implement process robustness improvements
through lean principals.
- Lead process specific training for the direct manufacturing
- Support internal and external audits for manufacturing process
- Support the PMO group for any technology transfer
- Own manufacturing process related change controls.
- Responsible for maintaining quality standards to meet GMP
requirements, CFR's and internal company policies with respect to
the manufacturing process.
- Responsible for providing manufacturing SME support on capital
related projects. Qualifications
- Minimum B.S. degree in Engineering or the life sciences and 5
years of work experience in biopharmaceutical based GMP
- Experience in the development of manufacturing documentation
and in the investigation of complex manufacturing deviations.
- In-depth knowledge of FDA regulations and GMP systems and
experience providing process support in a highly regulated or
pharmaceutical / biotech facility.
- Applied knowledge of Quality by Design, six-sigma, and
operational excellence tools in creating efficient and high-quality
processes and end products.
- Excellent oral and written communication skills. Strong
technical writing ability required.
- Travel as required to other internal sites, vendors, and CMOs
as required (-20%).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-AR1
Keywords: AveXis Inc., Durham , Manufacturing Specialist - Fill Finish, Other , Durham, North Carolina
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