Director, Generics Drug Formulation (Solid Oral Products or Injectables)

Kelun Pharmaceutical
Chengdu, China
Mar 27, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

Director of Genetics Formulation is responsible for formulation development, project management, and team development.

Key responsibilities:

·           Accountable for formulation development. Key activities include reviewing and revising development strategy and plans, evaluating research results, writing and approving submission documents, and solving key technical issues.

·           Manage project progress, resource planning and allocation, and ensure compliance of document submission with CFDA filing regulations.

·           Responsible for building development systems and establishing technology platforms.

·           Evaluate external technologies, resources, and drug development opportunities for in-licensing.

·           Responsible for building, managing, and training development teams.

Basic Qualifications:

·           Master’s degree or higher in pharmaceutical sciences or related fields.

·           A minimum of 10 years of industry experience in formulation and process development.

·           Familiar with manufacturing processes and ability of trouble-shooting.

·           Familiar with quality requirements of oral solid dosage forms, injectable formulation and process development, process validation and commercial production.

·           Familiar with international technical requirements of drug product development (including ICH, US FDA and EMA and CFDA) and regulations of drug product applications.

·           Knowledge of evaluation methods and requirements of formulation dosage forms, and ability to assess risks of BE studies and direct formulation development to improve the success rate of BE studies.

·           Familiar with the development and production of scale equipment systems, including their working principles, capabilities, and quality requirements.

·           Experience in team management, coaching and training of development teams.

·           Good English and Mandarin (preferred) language skills.