Quality Control Analyst - Microbiology (Multiple Positions)
Company: AveXis Inc.
Posted on: November 11, 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.The QC Microbiology Analyst performs
Environmental Monitoring and Microbiological testing in support of
manufacturing at the AveXis cGMP Manufacturing facility in Durham,
NC. The QC Microbiology Analyst responsibilities include, but are
not limited to, routine product and raw material testing,
environmental monitoring of the manufacturing cleanrooms and
processes, participate in method and instrument qualifications, and
support investigative testing. A potential candidate will possess
working knowledge of QC Microbiological/Cell Culture/Environmental
Monitoring testing techniques. The QC Analyst should be able to
work effectively within the group, within Quality, and cross
- Perform environmental and utilities monitoring in clean
- Perform bioburden, endotoxin and cell culture assays.
- Perform data entry.
- Assist in drafting and revising SOPs and reports.
- Trend EM data and publish quarterly and annual trend
- Assist with investigations to determine root cause of
environmental excursions and other non-conforming results and
implement appropriate corrective and preventative actions in a
- Establish and maintain library of environmental isolates.
- Assist in assay troubleshooting, qualification and
- Manage the use and maintenance of scientific equipment and
instrumentation and computer systems.
- Perform other duties as assigned. Qualifications
- Minimum B.A. or B.S. Microbiology or in scientific related
- Minimum of 2 years in a GMP Quality Control Microbiology/
Environmental Monitoring laboratories, preferably in a biologics
aseptic processing facility.
- Working knowledge of Environmental Monitoring and
Microbiological Assays (e.g. Bioburden, Endotoxin, Gram Stain, and
- Good understanding and demonstration of aseptic
- Ability to gown for entry into Aseptic core and supporting
areas, and lift approximately 25 lbs.
- Working knowledge of quality systems and regulatory
requirements (21 CRF Part 11/, ISO 14644-1, USP, EP, JP).
- Proficient in MS Word, Excel, Power Point and other
- Ability to communicate and work in a team environment.
- Comfortable in a fast-paced small company environment and able
to adjust workload based upon changing priorities.
- Self-motivated, detail-oriented, and willing to accept
temporary responsibilities outside of initial job description.
- Ability to think critically and demonstrate troubleshooting,
and problem-solving skills
- Excellent interpersonal, verbal, and written 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. #L1-GK1
Keywords: AveXis Inc., Durham , Quality Control Analyst - Microbiology (Multiple Positions), Professions , Durham, North Carolina
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