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 www.jazzpharmaceuticals.com for more information.
Job Description
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
#LI-SP1
#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. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits
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 www.jazzpharmaceuticals.com for more information.
Job Description
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
#LI-SP1
#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. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits