The Director of Drug Product Development will provide scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs across the development lifecycle, including preformulation, formulation, process development, technical transfer, and validation. This role leads cross-functional CMC teams and oversees drug product development from feasibility through commercialization, ensuring robust processes and regulatory compliance.
What You'll Do
- 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, and packaging (clinical and commercial).
- Develops 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.
- 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.
What We're Looking For
- 10 – 15 years’ experience in drug product development in the pharmaceutical industry.
- 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.
- 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.
- Master’s degree, PhD, or equivalent combination of education and work-related experience.
Nice to Have
- Experience in defending processes, procedures and investigation during Regulatory Agency inspections.
Benefits & Compensation
- Discretionary annual cash bonus or incentive compensation in accordance with the Company's Global Cash Bonus Plan or Incentive Compensation Plan.
- Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.
- Medical, dental and vision insurance.
- 401k retirement savings plan.
- Flexible paid vacation.
Compensation includes a base salary range of $198,400.00 - $297,600.00, discretionary equity grants, and discretionary annual cash bonus or incentive compensation.
Work Mode
Remote / Home Based with flexibility to travel on company business when required.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
