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
联系方式
上班地址:上海张江哈雷路866号
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