Reporting into the Snr Director Analytical Development, this is an opportunity to join the Small Molecule Development team within Jazz Pharmaceuticals. The role will provide scientific and technical leadership for analytical development at various stages of drug development both internal and external through CDMO, with particular emphasis on research and early development (pre‑DP0). It includes material characterization, analytical method assessment, forced degradation, development, transfer, validation and troubleshooting of methods. The position will lead analytical activities for research/early development programs and late stage development programs. Activities may be performed internally or with external vendors. Other responsibilities include cross‑functional team membership and/or leadership, authoring and/or reviewing method validation protocols and reports, technical reports, authoring or reviewing CMC aspects of regulatory dossiers and participation in department or functional initiatives.
The role will play a key part in shaping analytical strategies prior to DP0 and during IND enabling activities, 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 all methods are understood, robust, efficient, in control and phase appropriate.
The role is both project and operations orientated and requires an ability to drive and deliver multiple projects concurrently.
Essential Functions
Lead analytical method development, validation, transfer and stability evaluations, supporting early stage (pre‑DP0 through IND) and late stage development products both internally and externally by directing CDMO/CRO.
Define fit‑for‑purpose analytical packages and specifications for preclinical and early clinical programs, balancing speed, scientific understanding and regulatory expectations.
Represent analytical development on cross‑functional CMC product development teams, influencing candidate selection, developability assessment and early control strategy decisions.
Ensure that all analytical methods are in line with all applicable regulations, policies, guidelines and procedures.
Establish, justify and maintain shelf life and retest intervals for GLP and GMP materials using ASA P‑Prime modeling and/or stability study data.
Vendor management and oversight of workflow, progress and milestones at vendors, including early‑stage CDMO selection and analytical scoping.
Troubleshooting of analytical methods.
Clearly and effectively communicate ideas and results, written and verbal, to technical and non‑technical audiences.
Author and 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.
Keep current with developments in analytical methodologies and make recommendations for implementation of new methods or equipment.
Provide technical assessment during product acquisition due diligence as required.
Required Knowledge, Skills, and Abilities
Strong record of achievement in analytical development.
Substantial direct experience in small molecule analytical development, preferably in a pharmaceutical or biotech 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 minimal viable methods for early programs and progression to validated methods.
Demonstrated experience operating in ambiguous early development environments, including limited material, evolving processes, and incomplete analytical understanding.
Experience contributing to candidate selection, developability assessments, or early CMC strategy is highly desirable.
Demonstrated technical proficiency in analytical methodologies for both drug substance and drug product.
Experience in regulatory requirements for pharmaceutical products.
Experience in managing contract analytical organizations is highly preferred.
Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills, including ability to lead and drive performance of cross‑functional teams.
Excellent written and verbal communication skills with ability to multi‑task.
Demonstrated troubleshooting and problem‑solving skills.
Demonstrated track record of delivering positive results on a consistent basis.
Proven project management skills for technical programs.
Experience in managing and maintaining budgets desirable.
Required / Preferred Education and Licenses
Advanced degree BS/BSc/MSc in Chemistry, Pharm. Sci., Biochemistry, or related field.
Description of Physical Demands
Occasional mobility within office environment.
Routinely sitting for extended periods of time.
Constantly operating a computer, printer, telephone and other similar office machinery.
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