Associate Director, Drug Product Development

Associate Director, Drug Product Development

Jazz Pharmaceuticals is a global biopharma company dedicated to innovating and transforming the lives of patients and their families. They focus on developing life-changing medicines for serious diseases, often with limited therapeutic options. With a diverse portfolio in sleep disorders, epilepsy, and cancer treatments, Jazz Pharmaceuticals drives pioneering research and development in oncology and neuroscience. Headquartered in Dublin, Ireland, the company has R&D labs, manufacturing facilities, and employees worldwide.

The Associate Director, Drug Product Development provides scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs across various stages, including preformulation, formulation and process development, technical transfer, and validation. This role oversees drug product aspects from feasibility through clinical trial supply and technology transfer/commercialization. The Associate Director may also lead cross-functional CMC development teams, requiring broad experience in pharmaceutical product development, strong problem-solving skills, Module 3 authorship, robust manufacturing process development through designed experiments, and excellent project management and leadership abilities.

Essential Functions

• Leads the development of small molecule drug product formulations, appropriate to the phase of pharmaceutical development, with 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 in developing robust processes for pharmaceutical production.
• Directs projects and leads cross-functional teams (as required) with technical proficiency, scientific creativity, collaboration with others 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 performance of vendors.
• 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

• Greater than 10 years’ experience in drug product development in the pharmaceutical industry required. Direct experience with formulation development, process development, technical transfer and/or process validation.
• Demonstrated technical proficiency, engineering, collaboration with others, and independent thought. Strong teamwork skills.
• Demonstrated troubleshooting and problem-solving skills including the use of designed experiments, statistical process control.
• Development/authorship of CMC regulatory filings for pharmaceutical products.
• Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms 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 desirable.
• Proven project management skills for technical programs.
• Flexibility to travel on company business when required.

Required/Preferred Education And Licenses

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

Compensation and Benefits (for US Based Candidates Only)

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices. The full and complete base pay range for this role is $157,600.00 - $236,400.00. Individual compensation is determined by qualifications, skills, relevant experience, job knowledge, and other pertinent factors, ensuring fair and competitive pay aligned with expertise and contributions within the company's established pay framework and Total Compensation philosophy. Internal equity considerations also influence individual base pay decisions.

Beyond base pay, the successful candidate may be eligible for a discretionary annual cash bonus or incentive compensation, in accordance with the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants through Jazz's Long Term Equity Incentive Plan. Additionally, comprehensive benefits offerings include medical, dental, and vision insurance, a 401k retirement savings plan, and flexible paid vacation. More information on benefits can be found on the Jazz Pharmaceuticals careers website.

Key skills/competency

• Formulation Development
• Process Development
• Technical Transfer
• Process Validation
• CMC Regulatory Filings
• Project Management
• Vendor Management
• cGMP Compliance
• Small Molecule Development
• Intellectual Property