Quality Control Microbiology Supervisor - 2nd Shift
Company: AveXis Inc.
Posted on: January 16, 2020
OverviewReady 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.We are
seeking a highly motivated individual to join us as a QC
Microbiology Supervisor in our new gene therapy production center
located in Durham, NC. You will work with the Quality Control team
in supporting our efforts in this exciting new area of gene
therapy. In this role you will be responsible for the day to day
oversight of the QC Microbiology team. You will also be responsible
for the environmental and utilities monitoring, raw material
testing, and final product testing. Responsibilities
- Supervision of all QC Micro laboratory testing.
- Sustain environmental monitoring program for AveXis.
- Management and optimization of the Aseptic gowning training and
- Management of QC Microbiology training program.
- Work with QC raw materials team to establish specifications and
testing process of raw materials.
- SME on investigations of sterility failures and environmental
- Monitor and trend data
- Assemble reports on findings from environmental monitoring of
Avexis's cGMP facility. Frequently update management on
environmental trends. Implement corrective action plans when
- Complete routine record review of test data and related
documents for in-process testing, drug substance and drug product
release. Generation of CoAs for product release.
- Develop, revise and review SOPs, qualification/validation
protocols and reports.
- Conduct investigations regarding out of specifications (OOS)
results and address and manage non-conformances related to micro
- Provide updates at daily and weekly meetings.
- Monitor the GMP systems currently in place to ensure compliance
with documented policies.
- Review proposed changes to systems, procedures, methods, and
submissions to regulatory agencies, as appropriate.
- Gather metric information for use in continuous improvement of
areas of responsibility.
- Other duties as assigned.
- NOTE: Shift to include weekends and second shift hours within a
24x7 manufacturing environmnet. Qualifications
- Bachelor's degree or advanced degree in Microbiology or related
- Demonstrated leadership and management skills, including
establishing direction and goals, and guiding execution while
fostering a team based environment.
- A minimum of 5 years' experience working in the Environmental
Monitoring and Microbiology laboratories in an aseptic sterile
manufacturing facility is required. A minimum of 1 year experience
supervising/managing/leading microbiology and environmental
monitoring labs within the biotechnology or pharmaceutical
- The ideal candidate is well versed in various microbiological
techniques including rapid release methods, and qualifying
environmental monitoring processes with reference to cell/gene
- Experience in the application of microbiological techniques
such as air monitoring, water testing, surface monitoring, genus
and species identification of various microbes.
- The incumbent will need to have the ability to gown for entry
into Aseptic core and supporting areas, and lift up to 25 lbs.
- Working knowledge of quality systems and regulatory
requirements (21 CRF Part 11/210/211), Quality Control, cGMPs,
microbiological method development and validation.
- Strong data integrity knowledge and practices.
- Identifying, writing, evaluating and closing OOS
- Strong knowledge of aseptic manufacturing and EM
- Equipment and utility IQ/OQ/PQ/PV.
- Proficient in MS Word, Excel, Power Point and other
- Excellent interpersonal, verbal and written communication
skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment with
minimal direction and able to adjust workload based upon changing
priorities.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 Microbiology Supervisor - 2nd Shift, Hospitality & Tourism , Durham, North Carolina
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