Director, Drug Product Development (Home Based / Remote)

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma 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, 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. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

The Director of Drug Product Development is responsible for providing scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs at various stages of the development life-cycle including preformulation, formulation and process development, technical transfer and validation. The Director of Drug Product Development will oversee drug product aspects of development and manufacturing projects from pre-formulation and product feasibility through to clinical trial supply and technology transfer/commercialization. In addition, the Director of Drug Product Development will be expected to provide leadership of cross-functional CMC development teams.  The Director of Drug Product Development will have extensive experience in pharmaceutical product development, demonstrated problem solving ability, module 3 authorship, development of robust manufacturing processes through designed experiments and data analysis, and excellent project management, teamwork and leadership skills.

Essential Functions

• Leads the development of small molecule drug product formulations, appropriate to the phase of pharmaceutical development, with sufficient stability and robustness for clinical and/or commercial manufacturing.

• Responsible for specifying product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, required analytical methodology, packaging (clinical and commercial); and in developing robust processes for pharmaceutical production.

• Directs projects and leads cross-functional teams with technical proficiency, scientific creativity, collaboration with others to achieve project goals on time and within budget.

• Create intellectual property covering Jazz Pharmaceuticals products and ensure freedom to operate in the development of new drug products

• Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).

• Direct technical projects (internally and at CDMOs) including developing detailed technical work plans and managing performance of vendors.

• Work cooperatively with, or lead, internal