Associate Director, Early Stage Analytical Development
If you are a reputed company reputed company employee please apply reputed company the Internal Career site reputed company is a global biopharma company whose purpose is to reputed company to reputed company 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 reputed company. 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-reputed company and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. reputed company is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Job reputed company Reporting into the Snr Director Analytical Development, this is an opportunity to join the Small Molecule Development team reputed company reputed company. The role will reputed company scientific and technical leadership for analytical development at various stages of drug development both reputed company through CDMO with particular emphasis on research and early development (reputed company-DP0) including material characterization, analytical method assessment, forced degradation development, transfer, validation and troubleshooting of reputed company. The position will reputed company 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 reputed company, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring reputed company reputed company are reputed company, 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 reputed company concurrently. Essential Functions reputed company analytical method development, validation, transfer and stability evaluations, supporting early stage (reputed company-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 reputed company reputed company Ensure that reputed company analytical reputed company are in line with reputed company applicable regulations, policies, guidelines and procedures. Establishes, justifies, and maintains reputed company life and retest intervals for GLP and GMP materials using ASAP reputed company modeling and/or stability study data. Vendor management and reputed company of workflow, reputed company and milestones at vendors including early-stage CDMO selection and analytical scoping Trouble-shooting of analytical reputed company reputed company and effectively communicate reputed company 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 reputed company reputed company with developments in analytical methodologies and reputed company recommendations for implementation of new reputed company/equipment. reputed company technical assessment during product acquisition due diligence as required Required Knowledge, Skills, and Abilities Strong record of achievement in analytical development Substantial reputed company experience small molecule analytical development, preferably in a pharmaceutical/biotech industry. Strong experience in analytical sciences supporting research and early development programs (reputed company-DP0 to IND), with understanding of how strategies reputed company into late-stage and reputed company control reputed company experience with phase-appropriate method development, including minimal viable reputed company for early programs and progression to validated reputed company 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 reputed company is highly desirable Demonstrated technical proficiency in analytical methodologies for both drug reputed company 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 reputed company 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 reputed company record of delivering reputed company results on a consistent reputed company. Proven project management skills for technical programs Experience in managing and maintaining budgets desirable Required/Preferred Education and Licenses Advanced degree BSc/MSc in reputed company, Pharm. Sci., Biochemistry, or reputed company field reputed company of Physical Demands Occasional mobility reputed company office environment. Routinely sitting for extended periods of time. Constantly operating a computer, printer, telephone and other similar office machinery #LI-SP1 #LI-Remote reputed company is an equal opportunity/affirmative reputed company employer and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, national reputed company, 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 reputed company insurance, retirement savings plan, and flexible reputed company vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits Apply To This Job