Associate Director, Early Stage Analytical Development

About the role

Jazz Pharmaceuticals is seeking an Associate Director to lead early‑stage analytical development within its Small Molecule Development team. Reporting to the Senior Director of Analytical Development, you will shape analytical strategies from pre‑DP0 through IND enabling activities, ensuring robust, phase‑appropriate control of drug substances and products.

Key responsibilities

• Lead analytical method development, validation, transfer and stability studies for pre‑clinical, early clinical and late‑stage programs.
• Define fit‑for‑purpose analytical packages and specifications, balancing speed, scientific understanding and regulatory requirements.
• Manage collaborations with CDMOs/CROs, overseeing external method development and transfer.
• Author and review method validation protocols, technical reports, and CMC sections of regulatory dossiers.
• Participate in cross‑functional teams with Quality, Manufacturing, Regulatory and New Product Integration to drive agile product introduction.
• Drive multiple concurrent projects, ensuring timely delivery and alignment with overall development timelines.

Required profile

• Extensive experience in analytical development of small‑molecule drugs, covering early and late stages.
• Proven ability to lead cross‑functional projects and work with external partners.
• Strong understanding of CMC regulatory expectations and IND enabling activities.

Required skills

• Analytical method development
• Method validation
• Forced degradation studies
• Stability evaluation
• CDMO/CRO management
• CMC regulatory documentation

What we offer

• Opportunity to influence analytical strategy for innovative oncology and neuroscience therapeutics.
• Collaborative, science‑driven environment within a global biopharma leader.
• Access to state‑of‑the‑art laboratories and a diverse portfolio of marketed medicines.