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Senior Director, Analytical Development

Company: Jazz Pharmaceuticals
Location: Dublin
Posted on: May 17, 2022

Job Description:

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter. Brief Description: The Senior Director, Analytical Development provides scientific and technical leadership in respect of Analytical Development for projects at various stages of the drug development life cycle. Activities include analytical method assessment, development, transfer, validation and troubleshooting for drug substances and drug products, reference standard management, and stability program oversight. Success requires application of scientific principles and creativity to analytical design and development studies, and translation into commercially feasible, reliable and robust methods. Activities are performed internally or with external vendors. Other responsibilities include cross-functional team leadership and/or membership, authoring/review/approval of validation protocols and reports, and CMC aspects of regulatory dossiers, participating in due diligence and development of patent applications. The role will involve significant cross functional collaboration with other functions in Technical Operations, R&D, and Quality. An ability to drive and deliver multiple projects, while also leading and supporting a team of Analytical Development professionals is required. Essential Functions

  • Directs and leads the activities of the Analytical Development department, including budgetary responsibility
  • Leads or contributes to the strategy, planning, execution, and reporting for development projects
  • Supports product/process development and manufacturing areas to ensure a smooth transfer of technologies and products to contract sites.
  • Works closely with the other members of the Small Molecule Leadership Team to ensure the smooth running of the function.
  • Collaborates with other members of the Small Molecule Team to ensure dept or project objectives are delivered on time. Ensures risks are identified and mitigation plans developed and communicated.
  • Identifies and implements improvement initiatives in line with continuous improvement philosophy.
  • Ensures processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures Required Knowledge, Skills, and Abilities
    • Demonstrated leadership ability.
    • Broad experience in pharmaceutical development and manufacturing, with a strong emphasis on analytical development
    • Wide ranging experience in analytical development with a strong background in developing methods for both drug substances and drug products (especially OSDs), reference standard management, and stability program oversight. Experience in analysis and supply of materials for non-clinical studies is advantageous.
    • Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and development strategy
    • Experience in current regulatory requirements for pharmaceutical products, and in engaging with regulatory agencies. Direct experience in authoring of analytical and stability sections of NDA, MAA, IND and IMPD.
    • Excellent written and verbal communication skills, with a demonstrated ability to communicate ideas and results, written and verbal, to technical and non-technical audiences clearly and effectively.
    • Keeps current with developments in technologies & methodologies and makes recommendations for application to Jazz products.
    • Strong collaborative and team working skills.
    • Demonstrated troubleshooting and problem solving skills
    • Experience in the development of phase appropriate methods for early and late stage development programs is advantageous Required/Preferred Education and Licenses
      • B.Sc. in Analytical Science, Analytical Chemistry, Science or related field with M.Sc. or Ph.D. preferred. An equivalent combination of education and work-related experience would also be considered.
      • Minimum 10 years experience in analytical development in pharmaceutical industry, covering drug substances and drug products Jazz Pharmaceuticals is an Equal Opportunity Employer.

Keywords: Jazz Pharmaceuticals, Rancho Cordova , Senior Director, Analytical Development, Executive , Dublin, California

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