OverviewSenior Director, New Product & Technology Integration at Jazz Pharmaceuticals. This role reports to the Head, New Product & Technology Integration and is responsible for managing Technical Operations’ due diligence assessments of new product candidates, coordinating integration planning post-deal, and evaluating new technologies to support development/manufacturing programs and lifecycle management of Jazz products.This position serves as a critical liaison between Corporate Development, Technical Operations, and potential partners/licensors, requiring coordination across multiple functions and external resources.Essential FunctionsConduct due diligence in partnership with Corporate Development, maintaining pace, depth of diligence and engagement of internal resources. Provide feedback and strategic direction to improve efficiency of diligence process.Direct and oversee (as a matrix manager) diligence programs, coordinating inputs from expert consultants, Technical Operations and other departments as appropriate to the product/stage of diligence.Create and maintain assessment documents for each deal candidate, covering competence/compliance and risk for production technology, CMC approvability and robustness of supply chain.Develop and maintain summary CMC assessment covering major milestones for development, major product/process risks and potential mitigations for deal candidates and option programs.Develop and maintain knowledge of new pharmaceutical manufacturing technologies & processes in line with Jazz business objectives.Plan, oversee and monitor programs to integrate deal products/companies into existing functions and workflows within Technical Operations as a matrix manager.Engage, negotiate with, and maintain effective working relationships with potential/actual partners regardless of size or cultural background.Develop and maintain a portfolio of consultants covering a range of technical competencies related to due diligence and technology assessment.Create checklists, playbooks, templates and other tools to standardize and improve the diligence and integration processes.Required Knowledge, Skills, And AbilitiesExperience in managing drug substance/drug product process development from Discovery/Phase 1 to post-approval.Experience in development of a variety of both large and small molecules and the associated regulatory approval processes and challenges. Knowledge of global requirements highly desirable.Proven ability to manage technical assessment outside of specific background, engaging appropriate technical expertise and coordinating functional inputs to achieve desired result.Experience with diligence processes at various stages and with various technologies. Experience in integration programs highly desirable.Deep technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills with ability to multi-task.Clear technical writing, including sections of Module 3 and briefing documents for regulatory bodies and excellent oral communication skills are required.Proven leadership, project management and experience working in cross-functional teams in a matrix environment.Ability to mentor/influence across organizations and adapt to cultural norms and preferences.Required/Preferred Education And LicensesBachelors of Science, Master’s or Ph.D. in Pharmaceutical Sciences, Chemical/Biomedical Engineering, or a related field.At least 15 years of hands-on experience in drug development and validation, including experience in program outsourcing and management of CMOs/CROs.Experience from early feasibility to post-commercialization and deep technical knowledge in one or more areas.Description Of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods. Constantly operating a computer and related office equipment.Requirements associated with international and domestic business travel.Description Of Work EnvironmentWork indoors in a typical office environment with limited exposure to noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation. May occasionally move to different work locations.Work may require hours outside of normal business hours to meet business demands.Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will be eligible to participate in various benefits offerings, including medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.
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