Primary Respoibilities:

1、Establishes and builds a strong GMP compliant team and operatio.

2、Works with Regulatory, QA and senior management to develop, refine and eure compliance with all relevant regulatio.

3、Maintai knowledge of current best practices of manufacturing and supply chain planning. Identify emerging trends via statistical analysis and technologies and lead implementatiofeasibility assessment, as appropriate

4、Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigatio, as required.

5、Eures timely delivery of quality drug product to support clinical and commercial development in line with corporate goals and objectives and adjust pla as appropriate.

6、Eures products are produced and stored according to the appropriate documentation in order to obtain the required quality.

7、Eures the qualification and maintenance of the premises and equipment and appropriate validation is completed.

8、Eures the required initial and continuing training of his department peonnel is carried out and adapted according to need.

9、Communicate effectively with stakeholde and provide compreheive project analysis to senior management as required in the form of reports or presentatio as needed.

10、Particular expertise in validation and FDA/EMA audit experience highly desired.

11、Respoible for delivery of EHS and other Objective Key Results (OKR) and other delivery performance objectives as required.

EducatioExperiencekills:

1、BSc/MSc in Pharmaceutical Sciences, Chemical Engineering or related Life Sciences.

2、10+ yea’ experience in the pharmaceutical industry. 5+ year’s in Manufacturing Manager Role.

3、Proven success in delivering multiple product launches in manufacturing.

4、Exteive experience in validation, engineering, production planning and operation management. Prior experience in managing multiple functio such as upstream/dowtream related to manufacturing is highly desirable.

5、Ability to develop and implement production planning and scheduling.

6、Solid undetanding of FDA and EMA regulatory requirements.

7、Strong analytical and problem solving skills, and expected to lead troubleshooting in all areas of Manufacturing.

8、Excellent interpeonal, organizational, negotiation and communication (verbal and written) skills are essential.

9、Ability to think, plan, and influence strategically and diplomatically on the manufacturing priorities across multiple projects is necessary.

10、Must be a leader willing to be both a “coach and a player”.

11、Willingness to travel domestically and internationally as needed.