Senior Director, Biological Analytical Development (...

Reference #: R010668-16If 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 tou00a0transform the lives of patients and their families. We are dedicated to developingu00a0life-changing medicines for people with serious diseases - often with limited or nou00a0therapeutic options. We have a diverse portfolio of marketed medicines, including leadingu00a0therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.u00a0Our patient-focused and science-driven approach powers pioneering research and developmentu00a0advancements across our robust pipeline of innovative therapeutics in oncology andu00a0neuroscience. Jazz is headquartered in Dublin, Ireland with research and developmentu00a0laboratories, manufacturing facilities and employees in multiple countries committed tou00a0serving patients worldwide. Please visitmore information.Brief Description:The Senior Director, Biological Analytical Development is responsible for providing both leadership and hands-on technical expertise for analytical aspects of biologic CMC programs. This role combines strategic oversight with direct scientific contributions ensuring delivery of high-quality methods, specifications, and regulatory documentation to enable clinical development and regulatory submissions. The role can manage a team as well as external partners/CMOs, balancing mentorship and oversight with active participation in experimental design, data interpretation, and issue resolution.Essential FunctionsOwn and drive phase appropriate analytical development strategy for biologics programs from early clinical development through commercialisation, ensuring alignment with overall CMC and Pharmaceutical Development strategy.Serve as the analytical CMC lead for assigned programs, providing clear scientific judgment and decision making in cross functional forums with Drug Substance, Drug Product, Regulatory CMC, Quality, Manufacturing, and external partners.Define and implement analytical control strategies across the product lifecycle, including method scope, qualification and validation approach, specifications, stability programs, reference standards, extended characterization and comparability.Lead analytical input into process changes, tech transfers, PPQ, and lifecycle management activities, ensuring approaches are risk based, clinically relevant, and regulator ready.Personally author, review, and defend key analytical sections of regulatory submissions and responses, including IND, IMPD, BLA or MAA, comparability justifications, and health authority questions.Govern and oversee analytical activities at external CDMOs and contract laboratories, setting expectations, reviewing data critically, addressing underperformance, and ensuring inspection readinessProvide leadership to a small, senior analytical team through prioritisation, coaching, and development, while remaining sufficiently hands on to guide complex technical decisionsAct as a senior analytical thought partner in a lean development environment, balancing scientific rigor with pragmatism, speed, and resource constraintsContribute to and in some cases lead non technical strategic initiatives across PharmDev or CMC, such as operating model improvements, governance processes, portfolio prioritisation, or capability strategyWhere required, act as a CMC Development Team Lead or deputy, integrating analytical, DS, DP, regulatory, and quality considerations into a coherent program execution strategyParticipate in Analytical Development and broader CMC leadership forums, contributing to strategy setting across modalities and programsCommunicate clearly and credibly with internal stakeholders and external partners, adapting message depth and style to technical, regulatory, and executive audiencesTravel as needed to support DMO oversight, program reviews, and regulatory readiness activitiesRequired/Preferred Knowledge, Skills, and AbilitiesAt least 10 years experience in biologics analytical development across early and late stage development, including method qualification and validation from Phase 1 through approvalDemonstrated experience in biologics characterization and analytical comparability assessments supporting regulatory filingsExperience managing and governing external development and testing partnersDirect experience authoring analytical sections of regulatory submissions and addressing health authority questionsPreferred experience acting as a CMC Development Team Lead or senior CMC representativeDemonstrated ability to operate at both strategic and execution levels, with sound scientific judgment and independence of thoughtStrong collaboration and influencing skills in matrix environmentsExcellent written and verbal communication skillsRequired/Preferred Education and LicensesB.Sc. in Analytical Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or a related scientific discipline requiredM.Sc. or Ph.D. in a relevant discipline preferredThe 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: 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.

Created: 2026-02-04