Director, Drug Product Development (Home Based / Remote)

The Director of Drug Product Development is responsible for providing scientific and technical leadership for Jazz Pharmaceuticals' pharmaceutical development programs at various stages of the development life cycle including preformulation, formulation and process development, technical transfer and validation. The Director of Drug Product Development will oversee drug product aspects of development and manufacturing projects from pre formulation and product feasibility through to clinical trial supply and technology transfer/commercialization. In addition, the Director of Drug Product Development will be expected to provide leadership of cross functional CMC development teams. The Director of Drug Product Development will have extensive experience in pharmaceutical product development, demonstrated problem solving ability, module 3 authorship, development of robust manufacturing processes through designed experiments and data analysis, and excellent project management, teamwork and leadership skills.

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 with technical proficiency, scientific creativity, collaboration with others to achieve project goals on time and within budget.
• Create intellectual property covering Jazz Pharmaceuticals products and ensure freedom to operate in the development of new drug products.
• Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).
• Direct technical projects (internally and at CDMOs) including developing detailed technical work plans and managing performance of vendors.
• Work cooperatively with, or lead, internal and external teams as required.
• Author 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.
• Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.
• Assist other department team members in providing guidance/mentoring/reviewing documents/data in support of product development (e.g. clinical protocols, PK study results).
• Enhance and improve ways of working in Drug Product development, utilising knowledge of industry best practice.

Required Knowledge, Skills, and Abilities

• 10-15 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 track record in delivering achievements with meaningful impact in Pharmaceutical Development projects.
• Demonstrated ability to lead cross functional CMC Development teams.
• Demonstrated troubleshooting and problem solving skills including the use of designed experiments, statistical process control.
• Development/authorship of CMC regulatory filings for pharmaceutical products.
• Experience in defending processes, procedures and investigations during Regulatory Agency inspections desirable.
• Track record in generating intellectual property development.
• Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.
• Excellent written and verbal communication skills, with demonstrated ability to communicate at executive leader level.
• Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
• Proven project management skills for technical programs.
• Flexibility to travel on company business when required.

Required/Preferred Education and Licenses

• Master's degree, PhD, or equivalent combination of education and work related experience required.

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.