Jazz Pharmaceuticals · 4 days ago
Senior Director, Biological Analytical Development (Remote / Home Based)
United States
Full-time
Remote
Director/Executive
10+ years expJazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Senior Director, Biological Analytical Development is responsible for providing leadership and technical expertise for analytical aspects of biologic CMC programs, ensuring high-quality methods and regulatory documentation for clinical development and submissions.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
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
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
B.Sc. in Analytical Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or a related scientific discipline required
Preferred
Preferred experience acting as a CMC Development Team Lead or senior CMC representative
M.Sc. or Ph.D. in a relevant discipline preferred
Benefits
Medical, dental and vision insurance
Retirement savings plan
Flexible paid vacation
Company
Jazz Pharmaceuticals
Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.
1001-5000 employees
H1B Sponsorship
Jazz Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (24)
2023 (25)
2022 (31)
2021 (21)
2020 (39)
Funding
Current Stage
Public CompanyTotal Funding
$2.81BKey Investors
Longitude CapitalKohlberg Kravis Roberts
2024-09-03Post Ipo Debt· $850M
2021-04-22Post Ipo Debt· $1.5B
2009-12-07Post Ipo Debt· $120M
Leadership Team
Renée Galá
President and Chief Executive Officer
Dennis Engelke
Executive Director, Country Manager Switzerland & Austria
Recent News
2026-01-22
2026-01-16
Company data provided by crunchbase