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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.

Brief Description:

The Senior Director, Drug Product Development provides scientific and technical leadership for projects at various stages of the development lifecycle. Activities will cover formulation development, process development and manufacturing of small molecule drug products, which may be performed internally or with external partners. The range of technologies used will vary from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, and potential novel combination products (i.e., drug-device). 

The Senior Director, Drug Product Development is responsible for overseeing programs from the completion of product feasibility through commercial registration and launch. Success requires application of scientific and/or engineering principles and innovative thinking to drug product manufacturing process design and development studies, and translation into commercially feasible, robust formulation and processes. This role has high accountability in both technical and financial decision-making (program direction and development paths). This position reports to the Head of Drug Product Development.

Essential Functions

• Directs and leads the activities of the Small Molecule Drug Product Development team, including budgetary responsibility

• Leads or contributes to the strategy, planning, execution and reporting of development projects

• Supports product/process development and manufacturing areas to ensure a smooth transfer of technologies and products to contract sites.

• Works closely with the other members of the Drug Product Leadership Team to ensure the smooth running of the function

• Collaborates with other members of the Drug Product Team to ensure dept or project objectives are delivered on time. Ensures risks are identified and mitigation plans development and communicated.

• Identifies and implements improvement initiatives in line with continuous improvement philosophy

• Acts as Technical Operations Lead for cross-functional CMC Development teams, representing Technical Operations across various stakeholder groups within the organization.

• Leads the identification and selection of suitable drug product development and commercial manufacturing vendors.

• Prepares and/or reviews, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND/IMPD/NDA/MAA dossiers for the products that they manage.

• Supports asset due diligence and new product introduction and integrations.

• Identifies opportunity to create intellectual property covering Jazz Pharmaceuticals products.

Required Knowledge, Skills, and Abilities

• Demonstrated leadership ability

• Broad experience in pharmaceutical development and manufacturing, including early and late stage development, validation, and launch.

• Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.

• Experience in current regulatory requirements for pharmaceutical products, and in engaging with regulatory agencies. Direct experience in authoring drug product sections of NDA, MAA, IND and IMPD, and addressing regulatory agency questions.

• Ability to communicate ideas and results, written and verbal, to technical and non-technical audiences clearly and effectively.

• Capable of grasping complex technical issues and making sound decisions based on data and information from various sources.

• Proven project management skills for technical programs.

• Excellent communication skills and strong interpersonal skills. Demonstrated collaborative approach to projects with drug substance and analytical development colleagues.

• Experience in defending processes, procedures and   investigation   during   FDA/EMA inspections desirable.

• Experience in several of the following is desirable: solid dosage forms, controlled release formulations, combination products, parenteral products, API manufacturing, and analytical chemistry.

Required/Preferred Education and Licenses

PhD in Pharmaceutics/Pharmaceutical Science/Science/Engineering or equivalent along with 15 or more years’ experience in pharmaceutical industry.

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.

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 to the Head, New Product & Technology Integration, this role is responsible for managing Technical Operations’ due diligence assessments of new product candidates. This position will work closely with the Corporate Development department to ensure progress on the assessment is in sync with deal requirements.  A related responsibility is coordinating Technical Operations planning for the integration process post-deal and for the implementation of that plan after closure.  This is a critical liaison function between Corporate Development, Technical Operations, and the potential partner/licensor.

This role is also responsible to evaluate new technologies which may have a potential to facilitate Technical Operations’ development/manufacturing programs or life cycle management (LCM) of Jazz Products and to assess new product concepts which may be applicable to Jazz business interests.  For technologies or products deemed worthy of proof of concept (POC) assessment, this role is responsible to design and implement studies which will elucidate value and give insight into the development approach.

This role will depend heavily on resources external to NPTI, primarily contractors and consultants, and will involve significant coordination/collaboration with Technical Operations, Regulatory CMC, Commercial, Legal (both IP and Contracts), and Finance and leadership of this team in a matrix fashion for CMC.  The position has high accountability and visibility in terms of technical assessment, coordination inside and outside of Jazz, innovation and decision making

.

Essential Functions

• Conduct due diligence in partnership with Corporate Development, maintaining pace, depth of diligence and engagement of internal resources.  Provide feedback and strategic direction to improve efficiency of diligence process.

• Direct and oversee (as a matrix manager) diligence programs, coordinating inputs from expert consultants, Technical Operations and other departments as appropriate to the product / stage of diligence.

• Create and maintain assessment documents for each deal candidate, comprising inputs from consultants and Jazz functions with respect to competence/compliance and risk for production technology, CMC approvability and robustness of supply chain. 

• Develop and maintain summary CMC assessment covering major milestones for development, major product/process risks and potential mitigations for deal candidates and option programs. 

• Develop and maintain knowledge of new pharmaceutical manufacturing technologies & processes as required in line with Jazz business objectives

• As a Matrix manager, plan, oversee and monitor programs to integrate deal products/companies into existing functions and workflows within Technical Operations

• Engage, negotiate with, and maintain effective working relationships with potential/actual partners regardless of size or cultural background.

• Develop and maintain a portfolio of consultants covering a range of technical competencies apropos to due diligence and technology assessment. 

• Create checklists, playbooks, templates and other tools to standardize and improve the diligence and integration processes.

Required Knowledge, Skills, and Abilities

• Experience in managing drug substance/drug product process development from Discovery/Phase 1 to post-approval. 

• Experience in development of a variety of both large and small molecules and the associated regulatory approval processes and challenges.  Knowledge of global requirements highly desirable.

• Proven ability to manage technical assessment outside of specific background, engaging appropriate technical expertise and coordinating functional inputs to achieve desired result.

• Experience with diligence processes at various stages and with various technologies.  Experience in integration programs highly desirable.

• Deep technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills with ability to multi-task

• Clear technical writing, including sections of Module 3 and briefing documents for regulatory bodies and excellent oral communication skills are required.

• This position requires proven skills in leadership, project management and working in cross-functional work teams, including sensitivity and adaptability to cultural norms and preferences.  Significant experience as a matrix manager is required. 

• As a matrix manager, much of the work will be accomplished by mentoring/influencing.  Proven flexibility and adeptness in engaging all levels of the organization is a must.

Required/Preferred Education and Licenses

• Bachelors of Science, Master’s or Ph.D. degree in the fields of Pharmaceutical Sciences, Chemical/Biomedical Engineering, or a related field is required.

• At least 15 years of hands-on experience in drug development and validation, preferably in pharmaceutical or biotech company.  This must include experience in program outsourcing and management of CMOs/CROs.

• The ideal candidate will have experience from early feasibility to post-commercialization and one or more areas of deep technical knowledge.

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.

• Requirements associated with international and domestic business travel.

Description of Work Environment

• Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.

• Frequent computer use at workstation.

• May move from one work location to another occasionally.

• Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.

• Periodic business meetings and trade shows requiring appropriate business apparel.

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.