Quality Control Analyst (PCR) - 2nd Shift
Company: AveXis Inc.
Posted on: February 15, 2020
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 highly motivated and
solution-driven individual to join the dynamic and growing Quality
Control (QC) team. The individual will collaborate closely with
Analytical Development team to transfer analytical methods and
establish the site QC lab operations to support development and
commercialization of new gene therapy medicines. The QC Analyst is
responsible for routine sample testing under GMP or non-GMP modes,
laboratory maintenance, and participating in method
qualification/validations. A potential candidate should be able to
practice proper analytical techniques and have a working knowledge
of assay theories. The candidate should be able to adhere to all
GMP requirements, FDA/EMEA regulations, and have effective
interactions/communication with Quality management. The QC Analyst
may also support and identification and implementation of
corrective and preventive actions. He/she should be able to work
effectively within the group, within Quality, and across
- Perform established analytical methods such as ddPCR (Digital
PCR) and qPCR (Quantitative PCR) for in-process, release, or
- Perform other routine QC testing such as Physical testing (pH,
appearance, osmolality, sub-visible particulates), HPLC, SDS-PAGE,
Western Blot, etc.
- Participate in assay troubleshooting, qualification and
validation if needed.
- Manage the procurement, use, and maintenance of scientific
equipment, instrumentation, and computer systems.
- Write and revise documents such as SOPs and technical
- Support investigations to determine root cause of deviations
and non-conforming results and implement appropriate corrective and
preventative actions in a timely manner.
- Liaise with other departments including Analytical Development,
Quality Assurance, and Manufacturing to address compliance issues
and to implement corrective actions and to improve programs.
- Minimum B.A. or B.S. in biochemistry or related scientific
- 0-2 years GMP lab experience.
- Excellent oral and written communication skills.
- Solid technical writing experience required.
- Candidates must be open to shift work.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
Keywords: AveXis Inc., Durham , Quality Control Analyst (PCR) - 2nd Shift, Professions , Durham, North Carolina
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