Major Responsibilities and Duties:

• Potency assay development and management during CMC process development, budget control.

• Compliance audit and technical support on the CDMO.

• Trouble-shooting and technical investigation in terms of potency assay related affairs.

• Participate in the CTD files writhing and review.

Qualifications:

• 5 yeas and above experience of potency assay development and management.
• Good communicate skills and solve practical tech issues capability.
• Experienced in CDMO management. Familiar with GMP, ICH, pharmacopeia and other regulatory policy, to guide project to move forward.
• Master and above with majors in Biology, pharmacy, immunology and related. Good communication skills in English.
• Experience in BsAb development is a plus.

上班地址：浦东新区上科路88号豪威科技园区西塔8楼802室