Director, Protein Drug Analysis
Time：2023-09-01

Responsibilities

1. Lead the analysis team to be responsible for the whole process of analysis, project management and quality control;

2. Ensure that the analysis team is carried out in accordance with the specifications of the drug declaration process in the research and development process, and can meet the needs of official and unofficial audits, ensure that all platform construction and experimental work are compliant, and continuously optimize the laboratory management system during the work process;

3. Lead the establishment and implementation of the analysis platform, including the establishment of the activity method, physical and chemical method and characterization method platform, as well as personnel training, material management, project management, and quality standards;

4. Responsible for participating in the whole process of product project research and development, and maintaining close cooperation with other R&D departments: including project establishment, project goal formulation, project task decomposition, progress control, process construction, organization of new drug application materials, etc.;

5. Keep abreast of registration information and technical review updates, and take measures to achieve continuous improvement research and development goals;

6. Regularly collect research information on new drugs at home and abroad, timely follow up the update trend of analysis methods at home and abroad, and lay out the necessary analysis platforms and teams in advance;

7. Complete other tasks assigned by superiors.

Qualifications

1. Ph.D. in biology, chemistry and related majors;

2. Experience in specific analysis method development, more than 5 years of experience and at least 3 years of team management experience, experience in characterization methods is preferred;

3. Very familiar with new drug development and application and practical experience, directly involved in the writing of new drug application documents;

4. Experience in CRO/CMO project management and cooperation;

5. Good execution, team building, interpersonal communication and organization and coordination skills;

6. Good English communication skills, working experience in overseas pharmaceutical companies or multinational companies is preferred; Good problem analysis and problem solving skills.

E-mail：hr@kangabio.com