Title: Associate Director of Technical Transfer

Location: West Caldwell, NJ

Schedule: Monday – Friday (8am-5pm)

Type: Direct Hire

Start date: ASAP

Responsibilities:

• Supports Business Development in obtaining new opportunities by identifying processes, materials and equipment trains, developing project timelines and budgets, and reviewing contracts.
• Supports Finance in preparing COGS calculations by providing process technical information.
• Supports Engineering in preparing project capex budgets by identifying equipment trains.
• Executes tech transfer project plans by leading the internal project team comprising Business Development, Finance, Regulatory Assurance, Quality Assurance, Quality Technical Services, Engineering and Operations.
• Conducts placebo, technical, DOE, registration and validation batches as required to move a project from inception to commercialization.
• Supports the customer by writing and executing protocols, writing reports, investigations and other documents as required to file and launch pharmaceutical products.
• Identifies Critical Process Parameters and Critical Quality attributes.
• Supports the validation of analytical methods.
• Supports existing products by managing lifecycle projects (e.g. change in raw material)
• Plans resources for department; prioritizes and assigns projects and tasks
• Guides and motivates staff in the execution of their projects
• Coaches staff to develop their skills
• Evaluates staff performance; provides feedback to increase staff performance
• Reports on department achievements and project statuses
• Provides governance for department work processes
• Initiates continuous improvement projects for department workflows
• Networks with other department heads to facilitate cross-functional cooperation
• Serves as SME for tech transfer regulatory compliance

Requirements:

• Minimum Bachelors in science or engineering
• Subject Matter Expert in SUPAC guidelines
• At least 15 years’ experience in a pharmaceutical or related field
• Previous management skills: at least 10 years’ managing a tech transfer department in a pharmaceutical company
• Extensive experience in project management. PMP certification preferred.
• Extensive soft skills (communication, group dynamics, mediation, conflict resolution)
• At least 10 years’ previous experience performing technology transfer of pharma products
• Demonstrated performance developing tech transfer teams
• Must be able to simultaneously execute tech transfer projects and lead the department

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.