Associate Director, Early Stage Analytical Development

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 tr oubleshooting 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 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  

• 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  

• E nsure 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 Abil ities    

• 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   Educatio n and Licenses  

• Advanced degree   BS c /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.