Quality Control Microbiology Supervisor - 2nd Shift

Location
Durham, NC, US
Posted
Feb 29, 2020
Ref
2020-4906
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
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.

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 qualification program.
  • 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 excursions.
  • 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 necessary.
  • 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 procedures.
  • 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 discipline.
  • 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 industry.
  • The ideal candidate is well versed in various microbiological techniques including rapid release methods, and qualifying environmental monitoring processes with reference to cell/gene therapy product.
  • 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 investigations.
  • Strong knowledge of aseptic manufacturing and EM processes.
  • Equipment and utility IQ/OQ/PQ/PV.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • 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.

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