Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to life-changing medicines for people with serious diseases — often with limited or no We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. The Senior Director, Drug Product Development provides scientific and technical leadership for projects at various stages of the development lifecycle. Activities will cover formulation development, process development and manufacturing of small molecule drug products, which may be performed internally or with external partners. The range of technologies used will vary from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, and potential novel combination products (i.E., The Senior Director, Drug Product Development is responsible for overseeing programs from the completion of product feasibility through commercial registration and launch. Success requires application of scientific and/or engineering principles and innovative thinking to drug product manufacturing process design and development studies, and translation into commercially feasible, robust formulation and processes. This role has high accountability in both technical and financial decision-making (program direction and development paths). This position reports to the Head of Drug Product Development. Directs and leads the activities of the Small Molecule Drug Product Development team, including budgetary responsibility Leads or contributes to the strategy, planning, execution and reporting of development projects Supports product/process development and manufacturing areas to ensure a smooth transfer of technologies and products to contract sites. Collaborates with other members of the Drug Product Team to ensure dept or project objectives are delivered on time. Ensures risks are identified and mitigation plans development and communicated. Acts as Technical Operations Lead for cross-functional CMC Development teams, representing Technical Operations across various stakeholder groups within the organization. Leads the identification and selection of suitable drug product development and commercial manufacturing vendors. Prepares and/or reviews, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND/IMPD/NDA/MAA dossiers for the products that they manage. Supports asset due diligence and new product introduction and integrations. Identifies opportunity to create intellectual property covering Jazz Pharmaceuticals products. Broad experience in pharmaceutical development and manufacturing, including early and late stage development, validation, and launch. Experience in current regulatory requirements for pharmaceutical products, and in engaging with regulatory agencies. Direct experience in authoring drug product sections of NDA, MAA, IND and IMPD, and addressing regulatory agency questions. Capable of grasping complex technical issues and making sound decisions based on data and information from various sources. Proven project management skills for technical programs. Demonstrated collaborative approach to projects with drug substance and analytical development colleagues. Experience in defending processes, procedures and investigation during FDA/EMA inspections desirable. PhD in Pharmaceutics/Pharmaceutical Science/Science/Engineering or equivalent along with 15 or more years’ experience in pharmaceutical industry. 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 also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.