锦鲤求职岗位描述
Scientist/ Senior Scientist with expertise in formulation and process development of biologics, driving the design, optimization, and scale-up of innovative formulations and manufacturing processes for biologics like mAb, BsAb, enzyme, etc., ensuring compliance with regulatory standards, preferably with hyaluronidase experience.
Role & Responsibilities
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 requirements 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.