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Biologics Senior Scientist- Protein Formulation Development

Responsibilities:

  • 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

Basic Qualifications:

  • 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