Purification Development Scientist
和铂医药有限责任公司ShanghaiUpdate time: August 2,2019
Job Description
  • Lead/develop downstream processes for novel pipeline products and monoclonal antibodies for research and development efforts

  • Perform process optimization and validation based on design of experiment approaches of downstream processes for existing clinical products in preparation for Phase 3/commercial manufacturing

  • Lab-scale purification runs to support analytical, research, and GLP needs

  • Scale-up, tech transfer, and CMO manufacturing support

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

  • Manage Purification Development resources and strategic planning to support early and late stage projects.

  • 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 purification development

  • Contribute to the IND filings


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


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


2. Hands-on experience in purification techniques and in using AKTA systems


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


4. Expertise in purification scale-up principles, competency in planning and executing hands-on experimentation, and the ability to work well within a team dynamic in a fast-paced work environment


5. Experience with process analytics including HPLC, SDS-PAGE


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


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


8. Responsible, organized and disciplined record keeping


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


职能类别: 医药技术研发人员

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