(Assistant/Associate) Director of Bioassay Group- Analytical Center and QC

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.

Major Responsibilities

  • 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.

Requirements:

  • 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

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1F & 3F, Block A
2829 JinKe Road
Zhangjiang Hi-Tech Park
PuDong New Area
Shanghai China, 201203

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