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Analysis and R&D Director Top Apply

Number: 1人 Location: Suzhou Kunshan
Requirements: Doctor degree in analytical chemistry or related m Age: Over 30 years old
Academic Requirements: Above Doctor degree Language Skill: Skilled in Chinese and English writing and oral co
Date: 2017-3-21 Validity: 2017-12-21

Requirements: 

1Doctor degree in analytical chemistry or related major.

2Above 10 years’ pharmaceutical analysis experience in pharmaceutical industry (familiar with API and preparations analysis on all sides), above 5 years’ work    experience in analytical team management;

3Experienced in leading and analyzing R&D projects and those projects have been approved recently by Supervision Department in China, USA or EU;

4Using scientific and systematical methods to establish and carry out the analytical control strategy (including the quality standards) and stability study for novel drugs and generic drugs;

5Deep understanding and practical experience in the operation complying with the requirements of quality and regulations have succeeded to pass the GMP inspection and on-site inspection;

6Skilled in Chinese and English writing and oral communication.

7Strong ability in communication, a good team worker and strong team leadership.

Responsibilities:

1Providing reasonable design layouts to establish and optimize the analysis Lab., equipping the Lab. with necessary analytical instruments to support the development of API, preparation products and technics.

2Organizing a team which is professional on API and development of preparations (including the release of raw materials, preparation products of multiple dosage forms, center control and analytical support on innovative drug release techniques);

3Making training plans for Dept., providing necessary training on analysis techniques, quality control and laws and regulations;

4Formulating standard operation procedures and good operation instructions, and propelling the execution of them. Ensuring to meet the requirements in technology, quality and regulations;

5Guiding the analysis project team to establish analytical control policies, exploiting and verifying the analytical methods to ensure the development, clinic, production, registration and commercial production of API and preparation products;

6Leading and organizing the analytical dept. to proceed feasibility evaluation on new products, participating in project approval and management work of Pharmaceutical R&D Center.

7Knowing about the domestic and foreign Drug Administration regulations, making sure the R&D activities comply with the current law and regulations; Supporting the drug declaration work, answering the related questions from Supervision Department, supporting the on-site inspection to ensure the success in drug registration;

8Initiating and leading the technical cooperation with external cooperating organization, developing new analysis techniques or applications.

9Other related work assigned by supervisors.