Director, Formulation Development

Kelun Pharmaceutical
Chengdu, China
Mar 27, 2018
Required Education
Position Type
Full time

Director of Formulation Development is responsible for strategic planning, coordinating, and execution of product formulation development/characterization.

Key responsibilities:

·           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.

Basic Qualifications:

·           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.