Drug Product Development Lead (Associate Director)

Jazz Pharmaceuticals; United States; Remote; USD 158,000 - 236,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k retirement plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals is seeking an Associate Director of Drug Product Development to provide scientific leadership across preformulation, formulation and process development, tech transfer and validation. This role may lead cross-functional CMC teams and oversee development from pre-formulation to clinical supply and commercialization.

The ideal candidate brings extensive drug product development experience, problem-solving skills, and strong project management.

Qualifications

• >10 years in drug product development in pharma.
• Technical proficiency and teamwork skills.
• Experience with designed experiments and process validation.
• CMC regulatory filings development.
• Exposure to multiple drug delivery technologies.
• Strong written/verbal communication.

Responsibilities

• Lead development of small molecule drug product formulations with suitable stability for manufacturing.
• Specify product/process requirements including equipment, methods, materials, tests and packaging.
• Direct projects and cross-functional teams to achieve goals on time and within budget.
• Create IP covering Jazz products and ensure freedom to operate.
• Identify and select CDMOs/CMOs for development and manufacturing.
• Lead technical projects and manage vendor performance.
• Author CMC sections of regulatory dossiers for global regulators.
• Support due diligence and new product introductions.
• Apply cGMP knowledge to design and validate processes and manage vendors.

Skills

Drug product development

Team collaboration

Troubleshooting

CMC regulatory filings

Intellectual property

Project management

Travelability

Education

Advanced degree in Chemistry/Pharm. Sci./Engineering

Job description

Jazz Pharmaceuticals is seeking an Associate Director of Drug Product Development to provide scientific leadership across preformulation, formulation and process development, tech transfer and validation. This role may lead cross-functional CMC teams and oversee development from pre-formulation to clinical supply and commercialization.

The ideal candidate brings extensive drug product development experience, problem-solving skills, and strong project management.