Manager, Quality Control Microbiology

AveXis, Inc. in Libertyville, IL

  • Type: Full Time
position filled
**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. In this role you will be responsible for the day to day oversight of the Quality Control Microbiology team. You will also be responsible for the environmental monitoring program, raw material testing, in-process and final product testing. **Responsibilities** + Manage all Quality Control Micro laboratory testing and team. + Manage performance for the team, including goal setting and monitoring, ongoing feedback and performance evaluations. + Manage sample receipt, retain storage and disposal. + Sustain environmental monitoring program for AveXis. + Management and optimization of the Aseptic gowning training and qualification program. + Management of Quality Control Microbiology training program, develop training materials and continue to improve existing program. + Work with QC raw materials team to establish specifications and testing process of raw materials. + SME on investigations of sterility 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/cell culture 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. **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 10 years' experience working in the Environmental Monitoring and Microbiology laboratories in an aseptic sterile manufacturing facility is required. A minimum of 3 years' experience supervising/managing 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. + 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, on an as-needed. + Strong knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211). + Strong knowledge of GMP, SOPs and quality control processes. + Strong data integrity knowledge and practices. + Identifying, writing evaluating and closing OOS's and investigations. + Strong knowledge of contamination control, disinfection, cleanroom design and operation, aseptic techniques. + 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. + Flexibility to work weekends/overtime as needed. + Must be capable of bending, lifting, moving and/or carrying up to approximately 25 pounds. _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_ **Need help finding the right job?** We can recommend jobs specifically for you! **Job Locations** _US-IL-Libertyville_ **Posted Date** _2 months ago_ _(11/20/2019 1:08 PM)_ **_Job ID_** _2019-4590_ **_\# of Openings_** _1_ **_Category_** _Quality_ </script>

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