• Director, Manufacturing Process Science

    Job Locations US-CA-San Diego
    Posted Date 2 weeks ago(2 weeks ago)
    Job ID
    2018-2551
    # of Openings
    1
    Category
    Manufacturing
  • 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.

     

    In this leadership role, the Director will be responsible for the development and implementation of the manufacturing processes used to manufacture, as well as the data and reports to support IND applications of, AveXis gene therapy products. This individual will define and direct the activity with internal and external organizations to plan, execute, and document early manufacturing that define the product and process of new AveXis gene therapy candidates as well as implementing small and large-scale process science and development experiments as directed by the process and manufacturing science and technology groups.  The Director will oversee the raw materials and supply chain needs for manufacturing at the San Diego site.

    Responsibilities

    • Serving as a key scientific and technical representative for process-related issues at internal Avexis sites, as well as with external partners.
    • Recruit, train and manage the San Diego based Manufacturing Process Science Team, as well as establish the team’s annual performance goals and performance reviews based on company objective's.
    • Partnering with Manufacturing to meet the production schedule, ensure IND-enabling supply and uphold quality standards.
    • Partnering with Clinical and Regulatory to assure our product design support preclinical studies.
    • Partnering with Regulatory to support submissions and approval of product applications.
    • Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
    • Identifying and implementing potential process improvements in conjunction with manufacturing operations.
    • Participating in start-up efforts of new equipment, software or processes in manufacturing.
    • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
    • Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
    • Establishing small-scale production processes and using scaled-down lab processes to enable process troubleshooting.
    • Assist manufacturing by leading investigations in partnerships with Manufacturing, Quality, and other business units at the site, to determine root cause for variation, implement solutions, and ensure corrections are effective.
    • Participate in the collection and interpretation of data, and collaboration with other departments on all manufacturing related issues to drive issue resolution and support AveXis goals.
    • Own a portion of the process, planning to avoid delays, and leading the activity to deliver a robust and effective product and manufacturing process.
    • Proactive issue identification and risk management across the manufacturing process
    • Institute Best Practices and lessons learned from other AveXis manufacturing sites into the San Diego site

    Qualifications

    • Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field, Master’s degree of PhD preferred.
    • Excellent oral and written communication skills.
    • 15+ years of experience in biopharmaceutical based manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with:
    • Familiar with global regulations on devices, drugs, validation/qualification requirements
    • Excellent communication skills and attention to details.
    • Strong organizational skills and ability to multi task across projects and activities
    • Proven ability to build effective teams and participate on multi-disciplinary teams
    • Minimum 10 years leadership experience managing manufacturing staff

     

    Additional Requirements:

    Up to 40% 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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