• Manager, Incoming Quality Control

    Job Locations US-NC-Durham
    Posted Date 4 weeks ago(11/20/2018 6:45 AM)
    Job ID
    2018-2709
    # of Openings
    1
    Category
    Quality
  • 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. 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.

     

    The Manager, Incoming Quality Control serves as the owner for all work processes associated with the sampling and testing of incoming raw materials. This position oversees testing activities and ensures compliance with respect to sampling, methods, and procedures. Acts as a subject matter expert for Incoming Quality-related activities during regulatory inspections and as the document owner for procedures in support of the Quality Control Raw Material Programs. Responsibilities include, but are not limited to program management, technical writing, training, metrics, and investigations. 

     

    A potential candidate will possess a strong understanding of material sampling, analytical techniques, manufacturing operations, GMPs and the principles behind them. The individual must be able to communicate effectively, lead investigations and identify/implement CAPAs. 

    Responsibilities

    • Coordinates and performs timely, accurate and cGMP compliant testing of incoming raw materials.
    • Participates effectively with site functional teams including Manufacturing, Quality Assurance, Supply Chain and MS&T to achieve company objectives.
    • Determines appropriate analytical confirmatory testing of raw materials.
    • Ensures alignment with current relevant monographs.
    • Executes the guidelines to ensure the company has a robust raw materials program.
    • Executes proper investigation into the root cause of material and/or process failures and assists in determining appropriate material disposition and/or process improvements.
    • Ensures that internal and external laboratories comply with cGMP standards.
    • Collaborates with Quality, MS&T and/or outside contract labs to ensure seamless method qualification/validation and transfer.
    • Identifies and qualifies lab equipment.
    • Reviews and approves raw material qualification and testing documentation.
    • Supports interviewing and training of employees.

    Qualifications

    • Bachelor's degree in Chemistry, Biology or related sciences.
    • Minimum 5 years of relevant experience in GMP testing laboratory with 2 years of supervisory experience.
    • Strong understanding of cGMP regulations.
    • Strong understanding of compendial and non-compendial raw materials analytical testing and associated instrumentation used to perform raw material testing.
    • Strong problem-solving abilities.
    • Good critical thinking, deductive reasoning, and decision-making skills.
    • Deep experience with methods development and validation.
    • Ability to work independently and effectively, prioritizing and delivering on tight timelines.
    • Ability to work effectively within the site and across 3rd party testing laboratories.

    Approximately 10-15% travel required.

     

    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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