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

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

Join to apply for the Senior Director, Drug Product Development (Remote / Home Based) role at Jazz Pharmaceuticals

Senior Director, Drug Product Development provides scientific and technical leadership across the drug product development lifecycle. Activities cover formulation development, process development, and manufacturing of small molecule drug products, performed internally or with partners.

Responsibilities include:

• Directs and leads the Small Molecule Drug Product Development team, including budgetary responsibility.
• Leads or contributes to strategy, planning, execution, and reporting of development projects.
• Supports product/process development and manufacturing areas to ensure smooth transfer of technologies and products to contract sites.
• Collaborates with other members of the Drug Product Team to deliver department or project objectives on time, identifying risks and communicating mitigation plans.
• Identifies and implements improvement initiatives in continuous improvement philosophy.
• Acts as Technical Operations Lead for cross-functional CMC Development teams.Leads identification and selection of suitable drug product development and commercial manufacturing vendors.
• Prepares and/or reviews Chemistry and Manufacturing Controls sections of all IND/IMPD/NDA/MAA dossiers with Regulatory Affairs.
• Supports asset due diligence and new product introduction and integrations.
• Identifies opportunities to create intellectual property covering Jazz Pharmaceuticals products.

Qualifications:

• Demonstrated leadership ability.
• Broad experience in pharmaceutical development and manufacturing, early and late stage, validation, and launch.
• Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.
• Experience in current regulatory requirements for pharmaceutical products and engaging with regulatory agencies. Direct experience authoring drug product sections of NDA, MAA, IND, and IMPD, and addressing regulatory agency questions.
• Excellent written and verbal communication skills with ability to communicate ideas and results to technical and non-technical audiences.
• Capability to grasp complex technical issues and make sound decisions based on data and information from various sources.
• Proven project management skills for technical programs.
• Strong interpersonal skills and collaborative approach with drug substance and analytical development colleagues.
• Experience defending processes, procedures, and investigations during FDA/EMA inspections desirable.
• Experience in solid dosage forms, controlled release formulations, combination products, parenteral products, API manufacturing, and analytical chemistry desirable.

Education and Licenses:

PhD in Pharmaceutics/Pharmaceutical Science/Science/Engineering or equivalent along with 15 or more years’ experience in the pharmaceutical industry.

Jazz Pharmaceuticals is an equal opportunity 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.

Benefits include medical, dental, vision insurance, retirement savings plan, flexible paid vacation, and more. For more information on benefits click here:

Seniority level

• Director

Employment type

• Full-time

Job function

• Product Management and Marketing

Industries

• Pharmaceutical Manufacturing