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

Role Summary

The Senior Director, Drug Product Development provides scientific and technical leadership for projects at various stages of the development lifecycle. Activities will cover formulation development, process development and manufacturing of small molecule drug products, which may be performed internally or with external partners. The range of technologies used will vary from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, and potential novel combination products (i.e., drug-device).

The Senior Director, Drug Product Development is responsible for overseeing programs from the completion of product feasibility through commercial registration and launch. Success requires application of scientific and/or engineering principles and innovative thinking to drug product manufacturing process design and development studies, and translation into commercially feasible, robust formulation and processes. This role has high accountability in both technical and financial decision-making (program direction and development paths). This position reports to the Head of Drug Product Development.

Responsibilities

• Directs and leads the activities of the Small Molecule Drug Product Development team, including budgetary responsibility
• Leads or contributes to the strategy, planning, execution and reporting of development projects
• Supports product/process development and manufacturing areas to ensure a smooth transfer of technologies and products to contract sites
• Works closely with the other members of the Drug Product Leadership Team to ensure the smooth running of the function
• Collaborates with other members of the Drug Product Team to ensure dept or project objectives are delivered on time. Ensures risks are identified and mitigation plans development and communicated
• Identifies and implements improvement initiatives in line with continuous improvement philosophy
• Acts as Technical Operations Lead for cross-functional CMC Development teams, representing Technical Operations across various stakeholder groups within the organization
• Leads the identification and selection of suitable drug product development and commercial manufacturing vendors
• Prepares and/or reviews, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND/IMPD/NDA/MAA dossiers for the products that they manage
• Supports asset due diligence and new product introduction and integrations
• Identifies opportunity to create intellectual property covering Jazz Pharmaceuticals products

Qualifications

• Demonstrated leadership ability
• Broad experience in pharmaceutical development and manufacturing, including early and late stage development, 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 in engaging with regulatory agencies. Direct experience in authoring drug product sections of NDA, MAA, IND and IMPD, and addressing regulatory agency questions
• Ability to communicate ideas and results, written and verbal, to technical and non-technical audiences clearly and effectively
• Capable of grasping complex technical issues and making sound decisions based on data and information from various sources
• Proven project management skills for technical programs
• Excellent communication skills and strong interpersonal skills. Demonstrated collaborative approach to projects with drug substance and analytical development colleagues
• Experience in defending processes, procedures and investigation during FDA/EMA inspections desirable
• Experience in several of the following is desirable: solid dosage forms, controlled release formulations, combination products, parenteral products, API manufacturing, and analytical chemistry

Education

• PhD in Pharmaceutics/Pharmaceutical Science/Science/Engineering or equivalent along with 15 or more years‚Äô experience in pharmaceutical industry