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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.
Job Description
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 Functions
Own 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 readiness
Provide leadership to a small, senior analytical team through prioritisation, coaching, and development, while remaining sufficiently hands on to guide complex technical decisions
Act as a senior analytical thought partner in a lean development environment, balancing scientific rigor with pragmatism, speed, and resource constraints
Contribute 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 strategy
Where required, act as a CMC Development Team Lead or deputy, integrating analytical, DS, DP, regulatory, and quality considerations into a coherent program execution strategy
Participate in Analytical Development and broader CMC leadership forums, contributing to strategy setting across modalities and programs
Communicate clearly and credibly with internal stakeholders and external partners, adapting message depth and style to technical, regulatory, and executive audiences
Travel as needed to support CDMO oversight, program reviews, and regulatory readiness activities
Required/Preferred Knowledge, Skills, and Abilities
At least 10 years experience in biologics analytical development across early and late stage development, including method qualification and validation from Phase 1 through approval
Demonstrated experience in biologics characterization and analytical comparability assessments supporting regulatory filings
Experience managing and governing external development and testing partners
Direct experience authoring analytical sections of regulatory submissions and addressing health authority questions
Preferred experience acting as a CMC Development Team Lead or senior CMC representative
Demonstrated ability to operate at both strategic and execution levels, with sound scientific judgment and independence of thought
Strong collaboration and influencing skills in matrix environments
Excellent written and verbal communication skills
Required/Preferred Education and Licenses
B.Sc. in Analytical Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or a related scientific discipline required
M.Sc. or Ph.D. in a relevant discipline preferred
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
