药明生物
Proposal Support 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. - Generate and maintain technical documentation including protocols, reports and regulatory submission materials regarding formulation and process development. - Troubleshoot formulation and process issues during development and manufacturing. - Prepare technical proposals and provide detailed experimental procedures, timelines, deliverables, and pricing to support contract signing. - Liaise with project managers to ensure proposals align with client needs and company capabilities. - Monitor ongoing contracted projects, track deliverables, and assist in resolving any technical or scope-related issues during contract execution.
任职要求
Education - M.S. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field. Experience - Minimum 2-year experience in biological formulation and process development (industry or academia). - Experience in preparing technical documents and proposals, as well as experimental cost estimation. - Familiarity with GMP regulatory frameworks and quality standards for drug product manufacturing. Skills - Familiar with formulation and process development of biological drug products. - Strong organizational and project management skills to balance technical development and tender support tasks. - 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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