Scientist, Quality Control
Company: AveXis Inc.
Location: San Diego
Posted on: May 18, 2019
OverviewReady to join a team committed to moving gene therapies
into the clinical setting 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. We are at the beginning of an incredible
journey, and are looking for passionate individuals to join us on
this important mission.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.AveXis is seeking an experienced and exceptional Scientist/Sr.
Scientist to join the dynamic and growing quality control team to
perform bioassays suitable for lot disposition and characterization
of gene therapy drug products and substances.The individual will
play a crucial role for the performance of cell-based potency and
other functional bioassays in a team environment. In addition,
he/she will participate (or lead) method qualification/validation
in a cGMP setting and may be involved in the method transfer.
Responsibilities will also include execution of routine assays and
supporting lab operation. Successful candidate will have extensive
experiences in tissue culture work and will be a fast-learner with
passion for new technology and science.Responsibilities
- Perform and troubleshoot cell-based assays as well as other
plate-based assays using variety of platforms including but not
limited to ELISA, MSD, high-content imaging and
luminescent/fluorescent plate reader in support of release and
characterization assays for gene therapy products.
- Thorough understanding of quality systems and experience
leading investigations, non-conformances, change controls,
- Advanced technical writing skills.
- Maintain clean and fully functional cell culture area by
implementing TC room policy and take ownership of on-going cultured
cells by thoroughly documenting cell passage, morphology and
behavior and routinely performing tests for contamination. In
addition, create cell banks and oversee their inventory.
- Play an important role in qualifying and validating cell-based
assays. Author SOPs, method transfer/qualification/validation
protocols, and reports. Qualifications
- B.S or M.S in biology discipline is required.
- Minimum 8 years of biopharma industry experience is required
for B.S and minimum 5 years of biopharma industry experience is
required for M.S.
- Strong understanding of regulatory agency guidance such as FDA,
ICH and EMA and hand-on experience is a significant plus.
- Must have good cell culture techniques with good understanding
of cell behavior and biology.
- Demonstrated track record of successfully executing cell-based
assays using various assay platforms including but not limited to
ELISA, MSD, ELISpot and high-content imaging in 96 well plate
setting in a cGMP laboratory.
- Prior vivarium experience and direct exposure to/handling of
mice a plus.
- Broad experiences in cellular, biochemical and molecular
biological methods including but not limited to immunostaining,
flow cytometry, protein gel, Western blot, PCR and qPCR.
- Enjoy learning and challenges. Especially, must be able to
learn new instrument and master their software quickly.
- Ability to work in a fast-paced small but growing team
environment and to prioritize work from multiple projects. Must be
highly reliable and goals/deadlines oriented.
- Intelligent individual who respects others and is open to
- Must have exceptional organizational skills.
- Excellent written and verbal communication skills.This position
will be located out of our San Diego offices.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-JH1
Keywords: AveXis Inc., San Diego , Scientist, Quality Control, Other , San Diego, California
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