Associate Director, Drug Product Development

About the role

The Associate 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 role oversees drug product aspects of development and manufacturing projects from pre-formulation and product feasibility through to clinical trial supply and technology transfer/commercialization.

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.
• Specifies product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, required analytical methodology, packaging (clinical and commercial).
• 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.
• Supports 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.

Requirements

• More 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.

Qualifications

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

Skills

• Strong leadership and team collaboration skills.
• Proven experience in drug product development and process validation.
• Ability to develop and maintain strong working relationships with cross-functional teams.
• Expertise in regulatory affairs and compliance with cGMP and industry standards.
• Knowledge of intellectual property development and protection.

Benefits

Jazz Pharmaceuticals offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation. For more information on our benefits offerings, please visit here.