药明生物
Hypase Scientist/ Senior Scientist
岗位职责
The detailed responsibilities include but are not limited to the following: - Lead the formulation development for biologics (e.g., mAb, BsAb, fusion) in liquid, frozen, or lyophilized forms. - Lead drug product manufacturing process development and tech transfer to manufacturing sites. - Prepare technical proposals and reports regarding formulation and process development. - Troubleshoot formulation and process issues during development and manufacturing. - Responsible for establishing and maintaining the knowledge platform for hyaluronidase co-formulation, continuously improving the existing process. - Collaborate with preclinical teams to translate findings into formulation improvements. - Stay updated on evolving regulatory
任职要求
for biologics, especially hyaluronidase co-formulations. Education - Master in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field. Experience - Minimum 2-year experience in biological formulation and process development (industry or academia), preferably with hyaluronidase co-formulations. - Familiar with regulatory/quality management requirements for drug product manufacturing in a GMP environment. Knowledge or experience in hyaluronidase product or co-formulated product is a plus. - Hands-on experience with animal studies and PK/PD data analysis. Skills - Familiar with formulation and process development of biological drug products. - Familiar with typical analytical tools for biologics. Able to interpretate the data from common assays like SEC, iCIEF, CE-SDS, etc. - Understanding of animal model selection, dosing protocols, and ethical guidelines. - Fluent in both Mandarin and English. Strong skills in scientific writing and presentation. - Good communication skills, able to have clear and precise conversations in problem-solving.
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