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Manager, Quality Control Biochemistry

Company: AveXis Inc.
Location: Durham
Posted on: March 28, 2020

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. 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 the world's leading gene therapy company, redefining the possibilities for patients and families affected by life-threatening genetic diseases through our innovative gene therapy platform. Founded in 2013 and headquartered in Bannockburn, IL, the goal of AveXis' cutting-edge science is to address the underlying, genetic root cause of diseases. AveXis pioneered foundational research, establishing AAV9 as an ideal vector for gene transfer in diseases affecting the central nervous system, laying the groundwork to build a best-in-class, transformational gene therapy pipeline. AveXis received its first U.S. Food and Drug Administration approval in May 2019 for the treatment of spinal muscular atrophy (SMA). AveXis is also developing therapies for other genetic diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis (ALS) SOD1. Be a part of a team reimagining the treatment of rare and devastating genetic diseases with transformational gene therapies.The Manager, Quality Control Biochemistry will own all work processes associated with the Biochemistry laboratory including overseeing testing activities and ensuring compliance with respect to methods, protocols and procedures. This position will be the subject matter expert for Biochemistry related activities during regulatory inspections and the document owner for procedures in support of the Quality Control Programs. Responsibilities include, but are not limited to program management, technical writing, training, metrics, and investigations. The Manager, Quality Control Biochemistry must have a strong understanding of analytical techniques, manufacturing operations, GMPs and the principles behind them and be an effective communicator with the ability to lead investigations and identify/implement CAPAs. Responsibilities

  • Develops organizational structure and fosters talent management, including performance and succession planning, interviewing and training to support the company's business objectives.
  • Develops functional capabilities within the department to keep pace with advances in technology and company growth.
  • Creates a safe and dynamic work environment that supports an innovative, efficient and flexible organization.
  • Fosters a culture of compliance and excellence in quality throughout the company.
  • Develops departmental expertise in testing and documentation that will meet legal and regulatory requirements for products.
  • Develops cooperative and strong working relationships with Manufacturing, Quality Assurance and MS&T to achieve company objectives.
  • Develops and coordinates the Quality Control laboratory activities and capabilities to provide timely, accurate and cGMP compliant testing of raw materials, in-process materials, bulk and contract manufactured materials.
  • Guides the activities of the Quality Control group to ensure that the company has robust product stability programs for domestic and international products.
  • Oversees the approval of all specifications, procedures and formulas that impact the strength, quality, purity, and efficacy of manufactured and contract-manufactured products.
  • Ensures proper investigation into the root cause of product and/or process failures, and assists in determining appropriate product disposition and/or process improvements.
  • Ensures that internal and external laboratories comply with GMP standards.
  • Collaborates with MS&T and/or outside contract labs to ensure seamless method validation and transfer.
  • Participates in business sub-teams as a subject matter expert to provide input on timeliness and to address analytical/microbiological related issues.
  • Designs and implements laboratories at manufacturing facilities.
  • Accountable for Method Development, Qualification and Validation.
  • Ensures routine testing and generation of Certificate of Analysis. Qualifications
    • Bachelor's Degree in Chemistry, Biology or related sciences.
    • Minimum 8 years of relevant experience in GMP testing laboratory with 4 years of supervisory experience.
    • Strong understanding of cGMP regulations.
    • Understanding of analytical techniques such as ELISA, HPLC, Electrophoresis, Spectrometry, Physical Chemistry, etc.
    • Deep experience with methods d validation and transfer.
    • Ability to work effectively within the site and across 3 rd party testing laboratories.
    • Ability to work independently and effectively, prioritize and deliver on tight timelines.
    • Outstanding problem-solving abilities.
    • Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building.
    • Good critical thinking, deductive reasoning, and decision-making skills.Approximately 10% 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. #LI-GK1

Keywords: AveXis Inc., Durham , Manager, Quality Control Biochemistry, Executive , Durham, North Carolina

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