Job Description

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.

​​ReportingintotheSnr Director Analytical Development, this is an opportunity to join the Small Molecule Development team within Jazz Pharmaceuticals. The role will provide scientific and technical leadershipfor analytical developmentat various stages of drug developmentboth internal and external through CDMOwith particular emphasis on research and early development (pre-DP0)including material characterization, analytical method assessment,forced degradationdevelopment, transfer, validation and troubleshooting of methods. The position will lead analytical activities for research/early development programsandlate stagedevelopment programsActivities may be performed internally or with external vendors. Other responsibilities will include cross-functional team membershipand/or leadership, authoring and/or reviewing method validation protocols and reports, technical reports, authoring or reviewing CMC aspects of regulatory dossiersand participation in department or functional initiativesThe role will play a key part in shaping analytical strategies prior to DP0and during IND enablingactivities, where speed, pragmatism and phase-appropriate control strategies are critical.​

​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 allmethodsare understood, robust, efficient,in controland phaseappropriate

​The role is both project and operations orientated. Itshallrequireanability to drive and deliver multiple projects concurrently.​

Essential Functions

• Lead analytical method development, validation,transferand stability evaluations, supporting early stage(pre-DP0 through IND),andlate stagedevelopmentproductsboth internally and externally by directing CDMO/CRO.

• Define fit-for-purpose analytical packagesand specificationsfor preclinical and early clinical programs, balancing speed, scientificunderstandingand regulatory expectations

• Represent analytical development on cross-functional CMC product development teamsinfluencing candidate selection, developability assessment and early control strategy decisions

• Ensure that allanalytical methodsare in line with all applicable regulations, policies,guidelinesand procedures

• Establishes, justifies, andmaintainsshelf life and retest intervals for GLP and GMP materials using ASAP Prime modeling and/or stability study data.

• Vendor management and oversight of workflow, progress and milestones at vendorsincluding early-stage CDMO selection and analytical scoping

• Trouble-shootingof analytical methods

• Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences

• Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings

• Ensure a smooth transfer of analytical technologies to contract sites

• Keepcurrent withdevelopments in analytical methodologies and make recommendations for implementation of new methods/equipment.

• Provide technicalassessmentduring product acquisition due diligence asrequired

RequiredKnowledge, Skills, and Abilities

• Strong record of achievement inanalyticaldevelopment

• Substantial directexperiencesmallmoleculeanalytical development, preferably ina pharmaceuticalbiotech industry.

• Strong experience in analytical sciences supporting research and early development programs (pre-DP0 to IND), with understanding of how strategies evolve into late-stage and commercial control

• Direct experience with phase-appropriate method development, including minimalviablemethods for early programs and progression tovalidatedmethods

• Demonstrated experienceoperatingin ambiguous early development environments, including limited material, evolving processes, and incomplete analytical understanding

• Experience contributing to candidateselection, developability assessments, or early CMC strategy is highly desirable

• Demonstrated technicalproficiencyinanalytical methodologies forbothdrug substance and drug product

• Experience in regulatory requirements for pharmaceutical products

• Experience in managing contract analytical organizations is highlypreferred.

• Demonstrates potential for technicalproficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills, includingabilityto lead and drive performance of cross-functional teams

• Excellent written and verbal communication skills withabilityto multi-task.

• Demonstrated troubleshooting andproblem solvingskills

• Demonstratedtrack recordof delivering positiveresults on a consistent basis.

• Proven project management skills for technical programs

• Experience in managing andmaintainingbudgets desirable

RequiredPreferredEducation and Licenses

• Advanced degreeBScMScin Chemistry, Pharm. Sci., Biochemistry, or related field

of Physical Demands

• Occasional mobility withinofficeenvironment.

• Routinely sitting for extended periods of time.

• Constantlyoperatinga computer, printer,telephoneand other similar office machinery

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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