Associate Director, Early Stage Analytical Development

Description:

If 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 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

for more information.

​​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) including 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 will 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. It shall require 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. 

Establishes, justifies, and maintains shelf life and retest intervals for GLP and GMP materials using ASAP 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 

Trouble-shooting of analytical methods 

Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences 

Author and/or 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/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 small molecule analytical development, preferably in a pharmaceutical/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 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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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