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
联系方式
上班地址:上海张江哈雷路866号
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