Scientist, Process Science (Analytical)
Company: AveXis Inc.
Posted on: September 15, 2019
Overview Ready 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. AveXis is seeking an experienced and exceptional Scientist to
join the dynamic and growing analytical team to establish bioassays
suitable for lot disposition and characterization of gene therapy
drug products and substances. The individual will play a crucial
role for the development and optimization of novel potency and
other functional assays in a team environment. In addition, he/she
will participate in method qualification/validation in a cGMP
setting and may be involved in the method transfer to internal
and/or external QC laboratories. Responsibilities will also include
execution of routine assays and supporting lab operation.
Successful candidate may have expertise with AAV analysis and will
be adept and perceptive with passion for new technology and
science. Responsibilities Perform experiments in support of assay
development using variety of techniques covering cell biology,
biochemistry and molecular biology such as immunocytochemistry,
western blot, PCR, flow cytometry, and immunoprecipitation.
Optimize and troubleshoot assays using variety of platforms
including but not limited to ELISA, MSD, high-content imaging and
luminescent/fluorescent plate reader in support of developing
release and characterization assays for gene therapy products.
Thoroughly document optimization and troubleshooting processes.
Actively engage in planning and designing of assays/experiments and
take ownership of assays/experiments one is performing by
understanding the purpose, rigidly following through every step of
execution, thoroughly analyzing data and ensuring the data quality.
Play an important role in qualifying and validating novel assays.
Help documenting assay development, qualification and validation
processes as well as SOPs. Collaborate with R&D for knowledge
transfer during assay development and work closely with QC for
method transfer. Be actively involved (both as trainee and trainer)
in cross-training of lab personnel. Qualifications B.S, M.S, or PhD
in biology discipline is required. Minimum 5 years of biopharma
industry experience is required for B.S, minimum 3 years of
biopharma industry experience is required for M.S., and minimum 2
years of biopharma industry experience is required for PhD. Basic
understanding of regulatory agency guidance such as FDA, ICH and
EMA and hand-on experience is a significant plus. Demonstrated
track record of successfully optimizing and executing AAV
quantification using various assay platforms including but not
limited to HPLC, ELISA, MSD, ELISpot, qPCR, ddPCR and high-content
imaging in 96/384 well plate setting. 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 new/different ideas.
Must have exceptional organizational skills. Excellent written and
verbal communication skills. 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., Durham , Scientist, Process Science (Analytical), Other , Durham, North Carolina
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