Associate Director, Clinical Product Release
Company: AveXis Inc.
Posted on: April 18, 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.This position will be responsible for
performing release activities for clinical QA activities in support
of internal and external GMP activities for cell therapy products.
The candidate is expected to provide leadership for maintaining and
enhancing, in a phase-appropriate manner, the quality and
compliance culture. This candidate may describe themselves as
passionately devoted to their patients. And, if you are the kind of
person who dares to dream of something more than traditional
treatments and instead wants to be a vital part of making
transformational therapies a reality for patients who need it the
most, then this might be the right place for you.Responsibilities
- Generation and issuance of specific phase appropriate batch
- Manage batch release activities for clinical production
including but not limited to review of batch records, analytical
data with emphasis on the effect of safety and/or efficacy impact
to the clinical study, certificates of analysis, evaluation of the
IND and other documents.
- Provide direction for complex deviations and CAPAs in support
of batch release as well as understanding the specific impact on
preclinical and clinical studies.
- Provide status reports, including relevant quality metrics and
participate in the management review process.
- Partner with Supply Chain, Clinical Operations, Product
Development departments and CMOs to identify and implement GxP
procedures in compliance with regulations/guidelines.
- Periodically conduct audits to ensure that systems are operated
in accordance with established SOPs and GMPs.
- Support preparation for regulatory agency inspections and
participate as a Subject Matter Expert during regulatory GMP
- Provide quality assurance leadership, support, guidance and
direction to internal manufacturing and external quality teams
operating under phase appropriate cGMP regulations.
- Establish collaborative relationships with internal and
external customers to ensure all quality and compliance matters and
any issues that arise are addressed in an open and timely
- Actively manages department and site goals and objectives.
- Perform other duties as assigned. Qualifications
- B.S. or advanced degree in chemistry, microbiology or related
- Minimum 6-8 years of experience in the gene therapy /
biopharmaceutical industry and 2-3 years direct experience managing
preclinical and clinical quality release activities.
- Good knowledge of biologics cGMP manufacturing including
ideally recombinant protein and cell therapy cGMP
- Proven management skills with ability to work with high
performing teams, and lead others effectively.
- Experience with cGMP manufacturing of clinical trial
- Audit and investigation skills.
- Good verbal, written, and interpersonal communication
- Proficiency in Microsoft Office applications.
- Ability to operate in a fast-paced, multi-disciplinary
- Approximately 20% travel 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., Durham , Associate Director, Clinical Product Release, Healthcare , Durham, North Carolina
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