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Supervisor, Manufacturing GMP Cleaning

Company: AveXis Inc.
Location: Durham
Posted on: April 17, 2019

Job Description:

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.This position is responsible for supervising the cleaning team of the ISO classified clean rooms and associated activities as directed. Primary responsibilities include supervision of cleaning staff in applying cleaning solution to floors, ceilings, walls, fixtures, and equipment in conjunction with the proper cleaning equipment such as mops, wipes, bucket system, etc. following approved cleaning standard operating procedure. Individual will be directly responsible for a team of contractors whose direct responsibilities include performing GMP cleanings of different ISO clean room rated areas. The manufacturing supervisor will be the first line of contact to handle emergencies and perform routine inspections.Responsibilities

  • Ensure daily, weekly, and monthly cleaning of the clean rooms that include all classified areas using specified cleaning chemicals and is compliant with cGMPs and safety regulations.
  • Point person on shift to assign/distribute the work and coordinate emergency situations.
  • Lead investigations as related to GMP cleaning activities. Author deviations, non-conformances, and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
  • Ensure documentation (logbooks) are accurate and updated as required.
  • Ensure that all Standard Operating Procedures (SOPs) are followed and that all cleaning, disinfecting and documentation expectations adhere to the Good Manufacturing Practices (GMP) and Good Documentation practices (GDP).
  • This role is responsible for the accurate, safe, environmentally responsible, and quality compliant operations per cGMP expectations and SOPs.
  • Identify and implement opportunities to improve GMP cleanings.
  • Understand and be able to prepare chemicals properly and understand the contact time for all chemicals.
  • Read and understand all revisions of applicable assigned SOPs, policies and procedures.
  • Complete all training requirements for specific work areas and Maintain all training requirements for staff.
  • Interview and oversee contract employees.
  • Communicate and resolve issues that present themselves.
  • Exhibit safety leadership by example (e.g., utilize proper PPE when performing job functions).
  • Lead and mentor staff.
  • Handle HR related matters and communicate those issues effectively to the contractor.
  • Work flexible hours including holidays, weekends, overtime and special assignments. Qualifications
    • Previous supervisory experience and demonstrated ability to lead a team preferred.
    • Minimum High School diploma or equivalent.
    • A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing cleaning operations.
    • Solid knowledge of FDA regulations and GMP systems.
    • Excellent oral and written communication skills. Strong technical writing ability preferred.
    • Ability to don sterile protective equipment for entry into the cleanrooms. Previous Aseptic cleaning experience.
    • Must be able to lift over 35lbs and stand for extended periods of time. 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. #LI-GK1

Keywords: AveXis Inc., Durham , Supervisor, Manufacturing GMP Cleaning, Other , Durham, North Carolina

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