Associate Director, Drug Product Development

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. Associate Director of Drug Product Development The Associate 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 Associate Director 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, and may provide leadership of cross‑functional CMC development teams. The role requires broad 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 Lead 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. Specify product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, required analytical methodology, and packaging (clinical and commercial), and develop robust processes for pharmaceutical production. Direct projects and lead cross‑functional teams with technical proficiency, scientific creativity, and collaboration 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 and external teams as required. Author CMC sections of regulatory dossiers for products at all stages to enable acceptance by global regulators. Supports asset due diligence and new product introduction and integrations. Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations. Required Knowledge, Skills, and Abilities 10+ years of experience in drug product development in the pharmaceutical industry. Direct experience with formulation development, process development, technical transfer and/or process validation. Demonstrated technical proficiency, engineering, collaboration with others, independent thought, and strong teamwork skills. Demonstrated troubleshooting and problem‑solving skills including the use of designed experiments, statistical process control. Development/authorship of CMC regulatory filings for pharmaceutical products. Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms preferred. Excellent written and verbal communication skills. Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation. Experience in intellectual property development desirable. Proven project management skills for technical programs. Flexibility to travel on company business when required. Required/Preferred Education and Licenses Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work‑related experience required. Description of Physical Demands Occasional mobility within office environment; routinely sitting for extended periods of time. Constantly operating a computer, printer, telephone and other similar office machinery. 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.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices. For this role the full and complete base pay range is: $157,600.00 – $236,400.00. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The role may also be eligible for discretionary annual cash bonus or incentive compensation, discretionary equity grants, and participation in benefits offerings including medical, dental, vision insurance, 401(k) retirement savings plan, and flexible paid vacation. For more information on our benefits offerings please click here: #J-18808-Ljbffr Jazz Pharmaceuticals