Associate Director, Drug Product Development (Home Based/Remote)

Role Summary

The Associate Director of Drug Product Development provides scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs across the development life-cycle, including preformulation, formulation and process development, technical transfer and validation. They 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. They may provide leadership of cross-functional CMC development teams. The role requires broad experience in pharmaceutical product development, strong 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.

Responsibilities

• 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.
• 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.

Qualifications

• Required: More than 10 years’ experience in drug product development in the pharmaceutical industry; direct experience with formulation development, process development, technical transfer and/or process validation.
• Required: Demonstrated technical proficiency, engineering ability, collaboration with others, and independent thought; strong teamwork skills.
• Required: Demonstrated troubleshooting and problem-solving skills including the use of designed experiments, statistical process control.
• Required: Development/authorship of CMC regulatory filings for pharmaceutical products.
• Preferred: Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.
• Required: Excellent written and verbal communication skills.
• Required: Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
• Preferred: Experience in intellectual property development.
• Required: Proven project management skills for technical programs.

Education

• Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work-related experience required.

Additional Requirements

• Travel: Flexibility to travel on company business when required.