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Senior Director, Drug Product - Gene Therapy

Company: Ultragenyx Pharmaceutical
Location: Cambridge
Posted on: January 11, 2021

Job Description:

Senior Director, Drug Product - Gene Therapy Woburn, MA / Ultragenyx - Gene Therapy - Manufacturing and Plant Operations / Ultragenyx is a commercial-stage biopharmaceutical company committed to developing and commercializing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecules, biologics, gene therapies and nucleic acids to target debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. Ultragenyx Gene Therapy is headquartered in Cambridge, MA with additional locations in Woburn, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities!-- During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include remote based web-ex video discussions, interviews & onboarding. Position Summary The Senior Director, Drug Product role is an exciting, dynamic position intended to set-up and manage Ultragenyx first internal DP facility, inclusive of drug product manufacturing, and primary labeling and packaging. The Senior Director will oversee material supply and the departmental budget. The individual will be reporting to the Site Head for the Manufacturing facility. Responsibilities

  • Lead drug product manufacturing, engineering, and validation activities for the DP facility, staff recruitment and training,
  • Ability to work in a small company, fast-paced, environment, multi-task and contribute to many different functions.Resolve clinical and commercial manufacturing issues being mindful of Supply, Quality, and Regulatory through effective management of deviations and change control development and implementation, CAPA management and risk assessment.
  • Ensure ongoing production of timely, quality drug product by leading tech transfer, manufacturing, technical support, and process monitoring/trending activities
  • Establish and maintain an understanding of current trends, emerging process technologies and ensure full awareness of current and emerging global capabilities for DP production.
  • Execute Quality by Design (QbD) principles to define the design space and develop overall control strategy.
  • Develop technical summaries and contribute to regulatory filings.
  • Create, review and approve technical documents including batch records, engineering / development reports, Validation Master Plans and PPQ reports. Requirements
    • BS/MS in Engineering or Life Sciences or equivalent experience with minimum 12 years working in biotech company with focus on Development and Manufacturing collaborations
    • --Specific experience with DP operations a must.
    • Must be organized and have excellent oral and written communication skills.
    • Strong interpersonal skills.
    • Attention to detail is essential.
    • Must be able to handle confidential information and issues effectively.
    • Demonstrated proficiency on Microsoft office applications (Outlook, Word, Excel, Project, PowerPoint)
    • Ability to operate independently and seek out guidance and expertise internally and externally as needed.
    • Ability to identify and resolve problems in a timely manner and independently analyze information skillfully.
    • Team oriented, with a good sense of humor, sound judgment, self-motivation and willingness to take initiative.
    • Must be able to make informed risk decision and on occasion work with limited or rapidly changing data to drive timelines and decisions. #LI-CZ1 Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact--Talent Acquisition--by calling:--(415) 483-8800--or by--emailing--us . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed .

Keywords: Ultragenyx Pharmaceutical, Cambridge , Senior Director, Drug Product - Gene Therapy, Executive , Cambridge, Massachusetts

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