Senior Manager, Manufacturing Science and Technology
Company: AveXis Inc.
Posted on: June 16, 2019
OverviewReady to join a team committed to developing and
commercializing gene therapies for patients and families devastated
by rare neurological genetic diseases? AveXis is advancing
cutting-edge science, starting with our proprietary gene therapy
for the treatment of spinal muscular atrophy (SMA). We are in the
midst of an incredible journey and are looking for passionate
individuals to join us on this important mission.AveXis, a Novartis
company, is dedicated to developing and commercializing novel
treatments for patients suffering from rare and life-threatening
neurological genetic diseases. Our initial product is a proprietary
gene therapy approved by the US Food and Drug Administration for
the treatment of pediatric patients with SMA. In addition to
developing a treatment for SMA, AveXis also plans to develop other
novel treatments for rare neurological diseases, including Rett
syndrome and a genetic form of amyotrophic lateral sclerosis caused
by mutations in the superoxide dismutase 1 (SOD1) gene. The Senior
Manager is responsible for defining the technology transfer
strategy for the processes used to manufacture AveXis gene therapy
products at the site and contract manufacturing sites. Working with
Quality, Engineering and Manufacturing, this individual will
develop program level procedures for process tech transfer of
Avexis products globally. This will include leading the development
of tech transfer plans, protocols and reports for commercial and
clinical products at the site and contract manufacturers. In
addition, this individual will be the technical lead for process
tech transfers to the site and contract manufacturing
- Development of site and/or global procedures to govern process
tech transfers of gene therapy products.
- Serving as a scientific and technical lead for tech transfer
related issues and investigations at the site of manufacture.
- Partnering with Quality, Engineering and Manufacturing to
ensure robust process tech transfer plans, protocols and
- Mentor and train other team members.
- Provide technical leadership as required during start-up
efforts of new processes within manufacturing.
- Assisting in documenting changes/updates to manufacturing
processes and working with manufacturing, engineering and Quality
to implement those changes.
- Provide technical leadership for the transfer of new products
and processes to ensure smooth transition from process development
into GMP manufacturing.
- Identify opportunities to implement operational excellence and
- Build strong relationships with Quality to ensure a compliant
- Provide process expertise during health authority inspections
of AveXis products at the site.
- Provide technical process expertise to external
- Assist the external manufacturing team to resolve any issues
related to production issues at 3 rd party manufacturers.
- Completion of requisite training, as well as applicable
policies and procedures, related to the job function is an
expectation to support ongoing manufacturing support.
- M.S. degree in biochemistry, chemical engineering,
bioengineering, or related scientific field and at least 10 years
of experience in support of biopharmaceutical manufacturing OR
- B.S. degree in biochemistry, chemical engineering,
bioengineering, or related scientific field and at least 12 years
of experience in support of biopharmaceutical manufacturing
- Excellent oral and written communication skills.
- Experience in senior technical roles within a biopharmaceutical
based GMP manufacturing operations including direct experience in
cell culture, recovery, purification, and/or aseptic
- Familiar with global regulations on cGMP manufacturing of drug
substance, drug products devices, validation/qualification
- Strong technical writing ability.
- Proven ability to effectively lead and participate on teams.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 , Senior Manager, Manufacturing Science and Technology, Executive , Longmont, Colorado
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