The (Assistant /Associate) /Director of the bioassay group has the responsibility of leading a group of analytical development scientists & quality control analysts for the development, improvement, and execution of a variety of biochemical and cell based assays for demonstrating in vitro protein-target binding/functional activities, as well as cell based activities/functions, including cellular proliferation activity, activities related to apoptosis and cellular differentiation activities, and other bio-analytical methods for therapeutic antibodies, proteins. He/She will also have the responsibilities of transferring, validating and implementing a variety of bio-analytical/cell-based bioassays for supporting process development and GMP manufacturing of therapeutic antibody, protein drugs.
- Lead a group of analytical development scientists & QC analysts for conducting assigned projects & tasks in the areas described above to meet company, project goals, expectations in a tight timeline
- Lead the group for the development, transfer, validation and execution of various bioassays for supporting various process development and GMP manufacturing activities for therapeutic antibody and protein drugs
- Review, Draft, and approve SOPs related to the areas of bioassay group functions
- Validate, manage, and maintain relevant analytical instruments in good and sustainable operational conditions
- Manage internal and external projects, testing tasks, contracts effectively and efficiently
- Interact and collaborate with internal groups, departments, as well as external clients, customers effectively
- Write, review and approve technical documents, validation and other QC related documents, and make presentations for internal company use as well as for external clients, customers
- Lead the group for effective deviation, OOS investigation in a timely manner
- Manage group member performance effectively
- Prepare technical registration documents for regulatory submission.
- PD in Biology, Bio-analytical or other relevant fields with at least 5-10 years of relevant experience
- Proficiency in various biological & bio-analytical assay technologies, e.g., Cell-based assays including but not limited to ADCC/CDC, and Cellular Proliferation assays, ELISA, FACS, Mammalian cell culture, etc.
- Indepth understanding, knowledge, and experience in bioassay development, validation
- Demonstrated capability of developing various Bioassays independently
- Demonstrated capability of leading & managing a group of bio-analytical scientists for the execution of multiple projects in a fast-pace environment
- Solid GMP knowledge, experience, adequate knowledge of Quality Control operation
- Good oral and written communication skills in English and Chinese
- Be able to work effectively in a team oriented and fast pace
Location: ZJ Hi-tech Park,Shanghai, China