Biologics Senior Scientist- Protein Formulation Development
- Responsible to contribute and then lead the development of formulation for monoclonal antibodies, recombinant proteins, fusion proteins, antibody-conjugated drugs, and other biologics.
- Contributor in a formulation team and then lead the team in Shanghai, China to support formulation development, stressed studies, container closure system selection and process development for protein drugs or other parenteral drugs.
- Contribute to and then lead pre-formulation studies to characterize candidate molecule and elucidate degradation pathways to gain understanding of stability challenges and develop strategies for stabilization.
- Collaborate with analytical, cell culture and purification and fill/finish teams to lead the development and transfer of biosimiliars, new formulations, container closure systems and fill-finish technology to support toxicology study, clinical development, tech transfer, and process validation for internal or external partners.
- Collaborate with vendors, draft and then execute qualification of formulation and fill/finish instruments and equipments.
- Plan, assign, direct and evaluate the work of technical staff when assigned to the project to meet aggressive project timelines.
- Supervise lower level scientists and evaluate their performance.Present results internally and externally at weekly and monthly meetings with customers as well as industrial and scientific conferences
- Excellent written and verbal communication skills in both English and Mandarin Chinese.
- Hands-on some analytical instruments and methods such as DSC for liquid，DLS, CD，FTIR, SEC，IEX，SDS-PAGE，IEF，CE, UV spectroscopy, Karl Fischer coulometer, cIEF, Osmometer, particle counter and be able to interpret analytical data
- Hands-on and in-depth understanding of different protein chemistry characterization and stabilization techniques, as well as pharmaceutics relevant to drug product development including lyophilized, liquid and suspension dosage forms.
- Good understanding of GMP, pharmacopea testing and regulatory requirements for filing and registration of biologics with some knowledge of Quality by Design approach.
- Ph.D. degree preferably in pharmaceutical chemistry, biochemistry, biophysics, biology or engineering discipline
- The qualified candidate must be able to effectively partner with diverse team members from various functions at various levels in organizations.
- Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
Job Function: Research & Development
Primary Location: China-Shanghai