Director, Formulation Development

Employer
Kelun Pharmaceutical
Location
Chengdu, China
Posted
Mar 27, 2018
Ref
KL-009
Required Education
Doctorate/PHD/MD
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.