Analytical Biologics Scientist/Principal Investigator
BeiGene, Ltd
Beijing/Shanghai, China
About BeiGene
Over the past decade BeiGene has grown exponentially and become an industry leader with a robust drug pipeline combined with strong production capacity. In addition, as an emerging industry leader with over 7000 employees globally, BeiGene has built a world-class clinical development team and a leading commercial team to bring accessible and affordable medicines to patients around the world.
Responsibilities:
- Design and perform analytical analysis for biologics projects such as antibody, fusion protein and ADC, to support physicochemical properties and structual characterization during biological drug discovery. Literature search to solve problem as needed.
- Analytical screening to support cell line development and process development for early stage CMC project.
- Analytical method development for early stage CMC product QC and stability study.
- Analtyial support for tech transfer of bio-product from early stage to late stage.
- Draft SOP, study protocol and report to support biological product characterizaiton and comparability study.
- Support RS, DS, DP sample managenment and compliance to regulatory requirement.
Requirements:
- Master’s or PHD’s degree of analytical chemistry or biochem related background with 2-5 years of industrial experience.
- Highly self-motivated individual with hands-on experiences in analytical development for biologics large molecule like mAb, BsAb, fusion protein and ADC, including but not limited to HPLC, UPLC, LC-MS, CGE, CZE, ELISA.
- Support analytical development of biological products for drug-discovery and early CMC development.
- Well trained with QC’s basic operation sence.
- Familiar with analytical/characterization requirement for CTD document preparation.
- Experience with writing and reviewing development reports, SOPs, and record in English. Eglish oral communication will be a plus.
Submit your application:
- Interested applicants should submit a single pdf file containing a cover letter, curriculum vitae, representative publications and pre-prints, and a statement of research interests. Applicants will also be asked to provide the names and email addresses of three references.
- Applicants should submit their applications to daisy.da@beigene.com