Quality Control Analyst (Microbiology) - 2nd Shift (Gene Therapy)

Location
Durham, NC, US
Posted
Aug 28, 2020
Ref
5374
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready 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 qualify/validate 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. 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 functionally. NOTE: the working hours for this role is Wed-Sat from 5:00pm to 3:30am so it is considered a night shift role.

Responsibilities
  • Perform environmental and utilities monitoring in clean rooms.
  • 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 reports.
  • Assist with investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Establish and maintain library of environmental isolates.
  • Assist in assay troubleshooting, qualification and validation.
  • 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 field.
  • 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 Sterility).
  • Good understanding and demonstration of aseptic techniques.
  • 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 11/210/211/1271, ISO 14644-1, USP, EP, JP).
  • Proficient in MS Word, Excel, Power Point and other applications.
  • 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.

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