About Biopharmaceutical Contract Manufacturing

Boehringer Ingelheim aims to become China's first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China's biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China's innovative medicines in a bid to accelerate growth of China's bio-technology industry. The Company's state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.

Responsibilities

-Develop and qualification analytical methods independently for release testing, with special emphasis on release-related methods.

-Ensure that analytical methods are transferred smoothly from external parties and that the methods transferred out are robust, accurate and reproducible.

-Participate as Subject Matter Expert in internal or external project team meetings and client meetings and serve as main contact window for client in matters of analytical testing

-Ensure that IQ, OQ, PQ, PM and calibration are performed regularly

-Assist in building the quality system of Analytics.

-Complete other tasks assigned by the supervisor or line manager.

Qualifications

-Master’s degree or above: 5 years of analytical development experience in biopharmaceutical industry.

-Possess hands-on experience in release-related methods.

-Able to troubleshoot the cause of analytical failure.

-Possess in-depth knowledge of GMP and GDP regulations.

-Experienced in method qualification/validation.

-Experience of working in a GxP environment would be a plus.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.