Director Of Drug Product Development

The Director of Drug Product Development will be responsible for leading the Dosage Form and Drug Product teams. The Drug Product Development group is focused on development of pharmaceutical final-dosage forms including, but not limited to tablets, capsules, sachets, suspensions, multi-particulates, pediatric forms for oral, nasal, and pulmonary delivery. Experience with parenteral dosage forms is desired, but not required. The successful candidate will exhibit skills in tableting and capsule operations, prototyping, pilot batch development, formulation assessment, tech transfer to cGMP manufacturing, and identification of strategic drug product strategies and screening. The position will work closely with formulation, engineering, and operations teams to deliver products to our clients and patients.

Supervisory Responsibilities

• Work closely with other key stakeholders in the Process and Product Development team
• Provides mentorship
• Accountable for the daily workflow of the department
• Provides constructive and timely performance evaluations for direct reports
• Provide technical guidance and direction
• Has direct reports

Duties and Responsibilities

• Contributes to IR&D strategy
• Works directly with Executive Management on Company strategy, budgeting and forecasting
• Provides strategic vision for organization & department
• Performs other duties as assigned
• Authors/reviews/approves project proposals and budgets
• Delegation & oversight of new projects
• Makes final recommendations for capital expenditure to Executive Management

Required Skills and Abilities

• Scientific curiosity and willingness to learn
• Demonstrated ability to collaborate and lead cross-functional teams
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Excellent leadership and collaboration skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Demonstrated understanding of pharmaceutical processes and/or product development
• Strong analytical and problem-solving skills
• Extensive tablet development experience is a must, including expertise of basic materials characteristics and unit operations such as blending, granulation, compression and coating operations
• Excellent time management skills with a proven ability to meet deadlines
• Experience with aseptic dosage forms and fill finish operations is desirable, but not required
• Extensive experience developing solid oral dosage forms for clinical and commercial products

Education and Experience

• M.S. in Science or Engineering discipline with 12+ years experience
• PhD in Science or Engineering discipline with 5+ years experience
• B.S. in Science or Engineering discipline with 15+ years experience

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 25 pounds regularly and up to 50 pounds occasionally
• Motor skills required for basic laboratory operations (pouring liquids, using utensils to transfer powders, visual assessments)