Main responsibilities include:
The Manager & Associate Director & Director of the protein analytical chemistry 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 analytical methods for the analysis of proteins, antibodies, peptides, as well as chemicals, excipients., etc, in their concentration, size, identity, purity, impurity, product heterogeneity, conformation, structure, and other relevant chemical, biochemical, and biophysical characteristics. Besides leading the group to support various process development activities he/she will also have the responsibilities for transferring, validating and implementing a variety of analytical methods for supporting GMP manufacturing, QC testing of therapeutic antibody, and protein products for various clients, customers.
- 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 time line;
- Lead the group for the development, transfer, validation and execution of various analytical methods for supporting cell line development, as well as upstream and downstream process development and GMP manufacturing activities for therapeutic antibody and protein drugs, products for clients, customers
- Review, Draft, and approve SOPs related to the areas of analytical 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 biochemistry, analytical or other relevant fields with at least 5-10 years of relevant experience;
- Has indepth experience and working knowledge in use of multiple analytical technologies, including but not limited to UV/VIS, HPLC/UPLC, Capillary electrophoresis (CE), DSC, DLS, CD, FTIR for the analysis of proteins, antibodies, peptides, chemicals, excipients.
- Indepth understanding, knowledge, and experience in analytical method development, validation for therapeutic protein, antibody products
- Demonstrated capability of developing various analytical methods independently for therapeutic protein, antibody products
- Demonstrated capability of leading & managing a group of analytical scientists for the execution of multiple projects, testing activities 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: Shanghai, China