Formulation Development Scientist
和铂医药有限责任公司ShanghaiUpdate time: July 31,2019
Job Description
上海市 浦东新区
  • Lead/perform formulation development for novel pipeline products and monoclonal antibodies for research and development efforts

  • Lead/perform formulation and product development and stability assessment activities including candidate screening and selection, developing lyophilized or liquid formulations for all phases of clinical and commercial development

  • Develop fit-for-purpose analytical methods to support formulation development and research stability testing.

  • Compile data to support/contribute to technical/development reports for technology transfer and regulatory submission

  • Coordinate and collaborate with Discovery and other CMC functions and develop strategies to meet project as well as corporate timelines

  • Maintain scientific excellence and attention to detail

  • Design and conduct experiments, collect and analyze data, write development reports

  • Drive innovation through deep understanding of new technologies and methods in formulation development

  • Contribute to the IND filings


Requirements for Research Associate, Sr. Research Associate or Scientist:


1. BS/BA or MS or PhD in Chemistry, Chemical Engineering, Biotechnology, Biochemistry or related field. Number of years of industry experience commensurate with job titles


2. Hands-on experience in formulation techniques


3. Experience in formulation development for monoclonal antibodies, bispecific antibodies, Fc-fusions and other therapeutic proteins


5. Hands-on experience and trouble-shooting proficiency with applying chromatographic (HPLC, UPLC, column chromatography) methods, capillary electrophoresis and/or biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, Raman spectroscopy, particle analysis, etc.) for protein characterization are plus


6. Exceptionally strong communication and problem-solving skills and knowledge of Design of Experiment approaches for formulation optimization


7. Extensive knowledge and experience in IND filing


8. Ability to work independently and multitask in a fast-paced environment


9. Responsible, organized and disciplined record keeping


10. Self-motivated, collaborative, and effective communication skill


职能类别: 医药技术研发人员

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