<p><b>If you are a current Jazz employee please apply via the Internal Career site.</b></p>
<p>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
<a href=https://www.jazzpharmaceuticals.com target=_blank>www.jazzpharmaceuticals.com</a>
for more information.</p>
<div><div><p>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 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 Associate Director of Drug Product Development may provide leadership of cross-functional CMC development teams. The Associate Director of Drug Product Development will have 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.</p></div><p><b>Essential <span>Functions</span></b></p><ul><li><p>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.</p></li><li><p><span>Responsible</span> for <span>specifying</span> <span>product</span> <span>and</span> <span>process</span> <span>requirements, including</span> <span>manufacturing</span> <span>equipment</span> <span>and</span> <span>methods, performance</span> <span>criteria, materials, test</span> <span>protocols, required</span> <span>analytical</span> <span>methodology, packaging</span> <span>(clinical</span> <span>and</span> <span>commercial); and</span> <span>in developing</span> <span>robust</span> <span>processes</span> for <span>pharmaceutical</span> <span>production.</span></p></li><li><p><span>Directs</span> <span>projects</span><span> and leads cross-functional teams (as required) with</span> <span>technical</span> <span>proficiency,</span> <span>scientific</span> <span>creativity,</span> <span>collaboration</span> <span>with</span> <span>others to achieve project goals on time and within budget.</span></p></li><li><p>Create intellectual property covering Jazz Pharmaceuticals products and ensure freedom to operate in the development of new drug products</p></li><li><p>Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).</p></li><li><p><span>Direct technical</span> <span>projects</span> <span>(internally</span> <span>and</span> <span>at</span> <span>CDMOs)</span> <span>including</span> <span>developing</span> <span>detailed</span> <span>technical</span> <span>work</span> <span>plans</span> <span>and</span> <span>managing</span> <span>performance</span><span> of</span> <span>vendors.</span></p></li><li><p><span>W</span>ork <span>cooperatively</span> <span>with, or lead,</span> <span>internal</span> <span>and</span> <span>external</span> <span>teams as required.</span></p></li><li><p><span>Author</span> <span>CMC</span> <span>sections</span> <span>of</span><span> regulatory</span> <span>dossiers </span>for<span> products</span> <span>at</span><span> all</span> <span>stages to enable acceptance by global regulators. </span></p></li><li><p>Supports asset due diligence and new product introduction and integrations</p></li><li><p>Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.</p></li></ul><p><b>Required Knowledge, Skills, and <span>Abilities</span></b></p><ul><li><p><span>>10</span> <span>years</span><span>’</span><span> experience</span> <span>in</span> <span>drug</span> <span>product development</span> <span>in</span> <span>the</span> <span>pharmaceutical</span> <span>industry</span> <span>required.</span> <span>Direct experience</span> <span>with</span> formulation development, <span>process</span><span> development,</span><span> technical transfer and/or </span><span>process validation.</span></p></li><li><p><span>Demonstrated</span> <span>technical</span> <span>proficiency,</span> <span>engineering,</span> <span>collaboration</span> <span>with</span> <span>others, and</span> <span>independent</span> <span>thought. </span><span>Strong</span> <span>teamwork</span> <span>skills.</span></p></li><li><p><span>Demonstrated</span> <span>troubleshooting</span> <span>and</span> <span>problem-solving</span> <span>skills</span> <span>including</span> the <span>use</span> <span>of</span> <span>designed</span> <span>experiments, statistical</span> <span>process</span> <span>control,</span></p></li><li><p><span>Development/authorship</span><span> of</span> <span>CMC</span> <span>regulatory</span> <span>filings</span> for <span>pharmaceutical</span> <span>products.</span></p></li><li><p><span>Broad</span> <span>exposure</span> to <span>multiple</span> <span>drug</span> <span>delivery</span> <span>technologies</span> <span>and</span> <span>knowledge</span> <span>of</span> <span>standard</span> <span>dosage</span> <span>forms</span> preferred<span>.</span></p></li><li><p><span>Excellent</span> <span>written</span> <span>and</span> <span>verbal</span> <span>communication</span> <span>skills</span></p></li><li><p>Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.</p></li><li><p>Experience in intellectual property development <span>desirable.</span></p></li><li><p>Proven project management skills for technical programs.</p></li><li><p>Flexibility to travel on company business when required</p></li></ul><p><b>Required/Preferred Education and Licenses</b></p><ul><li><p>Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work-related experience required.</p></li></ul><p><b>Description of Physical Demands </b></p><ul><li><p>Occasional mobility within office environment. Routinely sitting for extended periods of <span>time.</span></p></li><li><p>Constantly operating a computer, printer, telephone and other similar office <span>machinery.</span></p></li></ul></div> <p><em>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.</em></p> <p><b><u>FOR US BASED CANDIDATES ONLY</u></b></p><p>Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $157,600.00 - $236,400.00</p><p>Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidates expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.</p><p>At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Companys Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazzs Long Term Equity Incentive Plan.</p><p>The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: <a href=https://careers.jazzpharma.com/benefits.html target=_blank>https://careers.jazzpharma.com/benefits.html</a>.</p>