Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Director of Biologics Device Development will provide technical evaluation and direction for the development and validation of combination products comprised of biologics with injectable devices. The AD will be responsible for manufacturing supplies of devices for preclinical and clinical studies and the successful execution of comprehensive technical and human factor studies required for regulatory approval of such combination products. The Director position has accountability for technical decision-making and will be a major contributor to the writing of Design History Files, Human Factor Studies protocols, technical development reports, as well as global regulatory submissions. The Director will need to coordinate with external partners the completion of device design development and customization, combination product risk assessments including design failure mode and effects analysis (dFMEA, pFMEA, uFMEA), device design verification and qualification. The Director will be responsible for the timely coordination of all device development operations and manufacturing campaigns according project timelines, cost and available resources. The Director will work with the Clinical, Quality, Regulatory, Supply Chain, other internal functions and external organizations to ensure that our combination products meet the highest standards for quality and supply and improve patients lives. This position reports to the Senior Director of Biologics Drug Product & Device Development.
Required Knowledge, Skills, and Abilities
Required/Preferred Education and Licenses
Description of Physical Demands
Description of Work Environment
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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.
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.