Director, Formulation Development
Director of Formulation Development is responsible for strategic planning, coordinating, and execution of product formulation development/characterization.
· Lead drug product formulation development by strategic planning, coordinating, and executing product formulation development/characterization.
· Determine and design dose forms of drug candidates based on projected clinical uses, physicochemical properties, IP and other relevant data.
· Responsible for selecting methods, techniques and evaluation criteria in compliance with regulatory policies.
· Interact closely with cross-functional teams and leaders on issues with projects, operational decisions, and timelines.
· Write and review reports for IND applications.
· Responsible for training, managing, and leading direct reports.
· PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8-year experience in a pharmaceutical development environment.
· 3+ year experience in leading small molecule formulation development with demonstrated examples of successful IND filings.
· Experience with multiple phases of product development is highly desirable.
· Excellent communication skills (oral and written).
· Knowledge of GMPs, CMC, regulatory rules and practices.
· Ability to work in a fast-paced, dynamic environment.
· Strong project and team leading skills.
· Good Mandarin and English language skills are essential.