Associate Director, Drug Product Development

Associate Director, Drug Product Development at Jazz Pharmaceuticals

Jazz Pharmaceuticals is a global biopharma company dedicated to transforming patient lives through innovation. We develop life-changing medicines for serious diseases, with a diverse portfolio including leading therapies for sleep disorders, epilepsy, and a growing pipeline in oncology and neuroscience. Headquartered in Dublin, Ireland, Jazz Pharmaceuticals is committed to serving patients worldwide through pioneering research and development.

The Associate Director of Drug Product Development will provide scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs. This role spans various stages of the development life-cycle, including preformulation, formulation and process development, technical transfer, and validation. You will oversee drug product aspects of development and manufacturing projects from initial feasibility through clinical trial supply and technology transfer/commercialization, potentially leading cross-functional CMC development teams. This position requires broad experience in pharmaceutical product development, strong problem-solving abilities, expertise in module 3 authorship, robust manufacturing process development via designed experiments and data analysis, and excellent project management, teamwork, and leadership skills.

Essential Functions

• Leads the development of small molecule drug product formulations, ensuring they are appropriate for the phase of pharmaceutical development and possess sufficient stability and robustness for clinical and/or commercial manufacturing.
• Responsible for specifying product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, required analytical methodology, packaging (clinical and commercial), and developing robust processes for pharmaceutical production.
• Directs projects and leads cross-functional teams with technical proficiency, scientific creativity, and collaboration to achieve project goals on time and within budget.
• Creates intellectual property covering Jazz Pharmaceuticals products and ensures freedom to operate in the development of new drug products.
• Supports the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).
• Directs technical projects internally and at CDMOs, including developing detailed technical work plans and managing vendor performance.
• Works cooperatively with, or leads, internal and external teams as required.
• Authors CMC sections of regulatory dossiers for products at all stages to enable acceptance by global regulators.
• Supports asset due diligence and new product introduction and integrations.
• Applies current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.

Required Knowledge, Skills, And Abilities

• Over 10 years’ experience in drug product development in the pharmaceutical industry is required, with direct experience in formulation development, process development, technical transfer, and/or process validation.
• Demonstrated technical proficiency, engineering aptitude, collaborative spirit, and independent thought. Strong teamwork skills are essential.
• Proven troubleshooting and problem-solving skills, including the use of designed experiments and statistical process control.
• Experience in the development and authorship of CMC regulatory filings for pharmaceutical products.
• Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms is preferred.
• Excellent written and verbal communication skills.
• Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
• Experience in intellectual property development is desirable.
• Proven project management skills for technical programs.
• Flexibility to travel for company business when required.

Required/Preferred Education And Licenses

An advanced degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related field, or an equivalent combination of education and work-related experience, is required.

Compensation and Benefits (US Based Candidates)

Jazz Pharmaceuticals is committed to fair and equitable compensation. For this remote role, the full and complete base pay range is $157,600.00 - $236,400.00. Individual compensation within this range will depend on factors such as qualifications, skills, relevant experience, and job knowledge. In addition to base pay, the successful candidate may be eligible for a discretionary annual cash bonus or incentive compensation and discretionary equity grants. Comprehensive benefits include medical, dental, and vision insurance, a 401k retirement savings plan, and flexible paid vacation.

Key skills/competency

• Drug Product Development
• Formulation Development
• Process Development
• Technical Transfer
• Process Validation
• CMC Regulatory Affairs
• cGMP Compliance
• Project Management
• Small Molecule Drugs
• Pharmaceutical Sciences