Director, Drug Product Development (Home Based / Remote)
Jazz Pharmaceuticals
5 hours ago
Remote
United States
$198,400 - $297,600 USD yearly
Operations
Application
- If you are a current Jazz employee, apply via the Internal Career site.
Essential Functions
- Lead development of small-molecule drug product formulations aligned to development phase with stability/robustness for clinical and/or commercial manufacturing.
- Specify product and process requirements (equipment/methods, performance criteria, materials, test protocols, analytical methodology, clinical/commercial packaging) and develop robust pharmaceutical production processes.
- Direct projects and lead cross-functional teams to deliver goals on time and within budget.
- Create intellectual property and ensure freedom to operate for new drug product development.
- Identify and select suitable drug product development and commercial manufacturing vendors (CMOs).
- Direct technical projects (internally and at CDMOs), including work plans and vendor performance management.
- Work cooperatively with, or lead, internal and external teams.
- Author CMC sections of regulatory dossiers at all stages.
- Support asset due diligence, new product introduction, and integrations.
- Apply cGMP and industry standards to manage vendors/CDMOs for process design and validation.
- Mentor/review documents and data supporting product development (e.g., clinical protocols, PK study results).
- Improve ways of working in Drug Product development using industry best practices.
Required Knowledge, Skills, and Abilities
- 10–15 years’ drug product development experience; direct experience with formulation development, process development, technical transfer and/or process validation.
- Technical proficiency, engineering judgment, collaboration, independent thought.
- Track record delivering impactful Pharmaceutical Development projects.
- Ability to lead cross-functional CMC development teams.
- Troubleshooting/problem-solving using designed experiments and statistical process control.
- Development/authorship of CMC regulatory filings.
- Desirable: experience defending processes/procedures during Regulatory Agency inspections.
- Track record generating intellectual property.
- Broad exposure to drug delivery technologies and standard dosage forms.
- Excellent written/verbal communication; can communicate at executive leader level.
- Current knowledge of quality systems and FDA/EU regulations for pharmaceutical development/validation.
- Proven project management for technical programs.
- Ability to travel as required.
Education
- Master’s degree or PhD, or equivalent combination of education and work-related experience required.
Benefits (US candidates)
- Medical, dental and vision insurance; 401k retirement savings plan; flexible paid vacation.
Physical Demands
- Occasional office mobility; routinely sit for extended periods; operate computer/printer/telephone.
- If you are a current Jazz employee, apply via the Internal Career site.
Essential Functions
- Lead development of small-molecule drug product formulations aligned to development phase with stability/robustness for clinical and/or commercial manufacturing.
- Specify product and process requirements (equipment/methods, performance criteria, materials, test protocols, analytical methodology, clinical/commercial packaging) and develop robust pharmaceutical production processes.
- Direct projects and lead cross-functional teams to deliver goals on time and within budget.
- Create intellectual property and ensure freedom to operate for new drug product development.
- Identify and select suitable drug product development and commercial manufacturing vendors (CMOs).
- Direct technical projects (internally and at CDMOs), including work plans and vendor performance management.
- Work cooperatively with, or lead, internal and external teams.
- Author CMC sections of regulatory dossiers at all stages.
- Support asset due diligence, new product introduction, and integrations.
- Apply cGMP and industry standards to manage vendors/CDMOs for process design and validation.
- Mentor/review documents and data supporting product development (e.g., clinical protocols, PK study results).
- Improve ways of working in Drug Product development using industry best practices.
Required Knowledge, Skills, and Abilities
- 10–15 years’ drug product development experience; direct experience with formulation development, process development, technical transfer and/or process validation.
- Technical proficiency, engineering judgment, collaboration, independent thought.
- Track record delivering impactful Pharmaceutical Development projects.
- Ability to lead cross-functional CMC development teams.
- Troubleshooting/problem-solving using designed experiments and statistical process control.
- Development/authorship of CMC regulatory filings.
- Desirable: experience defending processes/procedures during Regulatory Agency inspections.
- Track record generating intellectual property.
- Broad exposure to drug delivery technologies and standard dosage forms.
- Excellent written/verbal communication; can communicate at executive leader level.
- Current knowledge of quality systems and FDA/EU regulations for pharmaceutical development/validation.
- Proven project management for technical programs.
- Ability to travel as required.
Education
- Master’s degree or PhD, or equivalent combination of education and work-related experience required.
Benefits (US candidates)
- Medical, dental and vision insurance; 401k retirement savings plan; flexible paid vacation.
Physical Demands
- Occasional office mobility; routinely sit for extended periods; operate computer/printer/telephone.