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.
Reporting into the Senior Director, DS development, this role will provide scientific and technical leadership for drug substance development projects at various stages of the development life-cycle. Success requires application of scientific and/or engineering principles and creativity to process design and development studies, and translation into commercially feasible, reliable and robust processes. Experience of the critical interface attributes between drug substance and drug product will be especially relevant. Activities will be performed primarily with external contract development and manufacturing organisations (CDMOs).Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and CMC sections of regulatory dossiers, and participation in department or functional initiatives. The role will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control. The role is both project and operations orientated. It shall require an ability to drive and deliver multiple projects concurrently.Essential FunctionsLead the process development and cGMP manufacture of small molecule drug substances at CDMOsEnsure adequate supply of drug substance for clinical studies and other needsOversee the development of robust and reliable manufacturing processes utilizing Quality by Design (QbD) principles.Oversee the synthesis of chemical entities to support clinical and non-clinical studiesEnsure that all DS processes are in line with all applicable regulations, policies, guidelines and proceduresRepresent the drug substance team on cross functional project teams as neededWork closely with other cross-functional CMC project team members to deliver on agreed project goalsActively contribute to functional area continuous improvement initiativesAuthor and/or review drug substance sections of regulatory dossiers and technical reportsSupport other Technical Operations functions to ensure a smooth transfer of technologies and products to manufacturing sitesClearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiencesPlan, budget, execute and report on assigned projectsDevelop knowledge of new pharmaceutical manufacturing processes and technologies as required in line with Jazz business objectives and share best practices within teamsRequired Knowledge, Skills, and Abilities Strong record of achievement in drug substance development and manufacturing.Substantial experience required with a broad experience across drug development and manufacturing technologies but with specific experience related to drug substance chemical process development.Demonstrated technical expertise in chemical process development and new product introductionDemonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design to support process development objectivesDemonstrated troubleshooting and problem solving skills.Experience of CMC regulatory requirements for pharmaceutical productsDemonstrated track record of training and coaching colleagues to improve overall team process knowledge.Demonstrated track record of delivering positive results on a consistent basis.Proven project management skills for technical programsExperience in managing and maintaining budgets desirableExperience in defending processes, procedures and investigation during FDA/EMA (and other competent authorities) inspections desirable.Capability of grasping complex technical issues and make sound decisions based on data and information from various sourcesKnowledge of formulation development and/or large molecule technologies would be advantageousExcellent written and verbal communication skills.Required/Preferred Education and LicensesBachelor’s degree and PhD in ChemistryDescription of Physical DemandsOccasional 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. 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. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.