Director, Technical Development --- Downstream Process Owner
Company: AveXis Inc.
Posted on: May 22, 2019
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.AveXis is seeking a Director to lead the
development and improvement of the downstream manufacturing
platform processes used to manufacture, as well as the data and
reports to support approval of, AveXis gene therapy products. This
individual will define and direct the activity with internal and
external organizations to plan, execute, and document experiments
and early manufacturing that define the process, and method of
delivery to the clinical and commercial sites. The Director will
own and manage the process, analytical, and characterization
knowledge related to the production of AveXis gene therapy
products, and the raw materials need to make them.Responsibilities
of primary importance include ensuring the execution of
time-sensitive experiments, studies, and validation at external
partners while capturing related data and knowledge, to advance the
development of AveXis products from Research to Development, and on
to GMP manufacturing. The Director will be responsible for owning
the upstream portion of the platform processes, planning to avoid
delays, and leading the activity to deliver a robust and effective
product and manufacturing process. Responsibilities
- Serving as a key scientific and technical representative for
process-related issues at internal AveXis sites, as well as with
- Partnering with Clinical and Commercial to assure product
design supports safe and effective delivery to patients.
- Partnering with Manufacturing to meet the production schedule,
ensure commercial supply and uphold quality standards.
- Partnering with Regulatory to support submissions and approval
of product applications.
- Performing trending and monitoring of critical quality
attributes/critical process parameters to maintain product quality
and to control process drift.
- Identifying and implementing potential process improvements in
conjunction with manufacturing operations.
- Participating in start-up efforts of new equipment, software or
processes in manufacturing.
- Assisting in documenting changes/updates to manufacturing
processes and working with manufacturing, engineering and
validation to implement those changes.
- Reviewing/providing feedback and technical/scientific support
on project deliverables, i.e. remediation initiatives, plan
- Establishing small-scale production processes and using
scaled-down lab processes to enable process troubleshooting.
- Lead 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
- Participate in the collection and interpretation of data, and
collaboration with other departments on all manufacturing related
issues to drive issue resolution and support AveXis goals.
- Ensure all documentation and reports are accurate, complete,
and suitable for using in support of production, characterization,
and regulatory approval of AveXis products. Qualifications
- Bachelor's degree in biochemistry, chemical engineering,
bioengineering, or related technical field.
- Master's degree of PhD preferred.
- Excellent oral and written communication skills.
- 15-30 years of experience in biopharmaceutical based GMP
manufacturing operations including direct experience in cell
culture, recovery, purification, aseptic fill/finish.
- Familiar with global regulations on devices, drugs,
- Excellent communication skills and attention to details.
- Strong organizational skills and ability to multi task across
projects and activities.
- Proven ability to effectively lead and participate on
- Minimum 10 years leadership experience.Approximately 20% to 50%
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-GK1
Keywords: AveXis Inc., Cary , Director, Technical Development --- Downstream Process Owner, IT / Software / Systems , Durham, North Carolina
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