Quality Control Specialist (Microbiology)
Company: AveXis Inc.
Posted on: September 13, 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 Quality Control Microbiology Specialist
provides Environmental Monitoring/Microbiological support at the
AveXis GMP Manufacturing facility. The QC Microbiology Specialist
responsibilities include, but are not limited to, training, data
review, routine testing, method qualification/validations,
investigations, and technical writing. A potential candidate will
possess a strong technical understanding of QC Microbiological/Cell
Culture/Environmental Monitoring testing techniques. The QC
Specialist should be able to work effectively within the group,
within Quality, and cross functionally. Responsibilities
- Perform Cell Culture Assays, Environmental Monitoring, and
- Review and trend data and publish quarterly and annual trend
- Conduct thorough investigations to determine root cause of OOS
investigations and other non-conforming results and implement
appropriate corrective and preventative actions in a timely
- Liaise with other departments including Quality Assurance,
Manufacturing, and Facilities to address compliance issues,
implement corrective actions and improve programs.
- Participate in assay troubleshooting, qualification, and
- Manage the use and maintenance of scientific equipment,
instrumentation and computer systems.
- Write and revise documents such as SOPs and technical reports.
- Minimum B.A. or B.S. Microbiology or in scientific related
- Minimum of 5 years in a GMP Quality Control Microbiology/
Environmental Monitoring laboratories, preferably in a biologics
aseptic processing facility.
- Strong knowledge of Environmental Monitoring and
Microbiological Assays (e.g. Bioburden, Endotoxin, Gram Stain,
Microbial ID, and Sterility).
- Ability to gown for entry into Aseptic core and supporting
areas, and lift approximately 25 lbs.
- Experience with method and instrument qualification.
- Experience performing laboratory investigations and
environmental monitoring excursion investigations.
- Experience with classroom and on the job training (i.e.
Microbiological Assays, Aseptic Techniques, and Aseptic
- Good understanding and demonstration of aseptic
- Experience leading small teams and projects.
- 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
- 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-TT1
Keywords: AveXis Inc., Durham , Quality Control Specialist (Microbiology), Other , Durham, North Carolina
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