The Associate Director/Director of Analytical Development & Protein Characterization Group is responsible for leading the group for carrying out analytical development activities, as well as protein/antibody characterization activities for biologics drug products. He / she is mainly responsible for leading the team to develop a variety of analytical methods for supporting testing of biologics drug products, as well as to analyze biologics products by using a variety of analytical characterization techniques, methods, including but not limited to mass spectrometry, liquid chromatography, and other biophysical, biochemical techniques aiming at supporting CMC and/or research, development activities of biologics drug products for clients.
Main responsibilities include
- Lead the team of analytical scientists to develop analytical methods and transfer the methods to Quality Control organization for testing biologics drug products
- Effectively manage the team to carry out various product/antibody characterization work using a variety of techniques/methods, including but not limited to mass spectrometry, liquid chromatography, LC-MS, and other biophysical, biochemical techniques in order to support the development of CMC biologics drug products for clients, as well as to support contract testing of products, samples from clients to meet the needs of clients for various purposes.
- Effectively manage the work flow of analysts and instrument use in order to achieve the highest working efficiency
- Effectively manage and maintain the analytical instruments in the regulated environment, ensuring good and sustainable operating conditions for the instrument to meet the analytical testing requirements, project needs
- Write and approve technical reports, documents for the development and characterization of biologics products, samples for clients
- Communicate closely with internal teams, including QC, Process development, business development, as well as project management teams for effective execution of all of the contract projects
- Effectively manage the performance of team members
- Conduct hiring of new team members, ensuring team’s adequate analytical capacity for meeting project execution needs
- Conduct technical interaction and communication, presentation with internal teams and external clients
- Ph.D. with at least 10 years of experience in protein chemistry, analytical chemistry, mass spectrometry, biochemistry, biophysics or other related fields
- In depth experience and knowledge of protein chemistry and mass spectrometry, biochemistry, analytical chemistry, biophysical analysis. Experience with IND filing applications of biologics drug products (NMPA, FDA)
- Familiar with and master the following analytical techniques for biologics product characterization, including but not limited to mass spectrometry / LC-MS, liquid chromatography, Biacore, DSC, CD, etc
- Ability to lead and manage the analytical team, be able to execute multiple projects and related analytical activities in a fast-pace working environment.
- Excellent communication skills in both Chinese and English, including oral and written communication skills
- Able to work effectively in a team work and fast environment.
Location: ZJ Hi-tech Park,Shanghai, China