Associate Development Manager

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to life-changing medicines for people with serious diseases — often with limited or no 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. 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 .   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 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. ​  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   ~ 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.   ~ 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 in regulatory requirements for pharmaceutical products   ~ Strong teamwork skills , including   ability   to lead and drive performance of cross-functional teams .   ~ Proven project management skills for technical programs    ~ Biochemistry, or related field   Occasional mobility within   office   environment.   Constantly   operating   a computer, printer,   telephone   and other similar office machinery #LI-Remote 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.