岗位职责: Main Responsibilities 80Develop, validate and transfer bioassays for IND enabling or clinical stage projects 80Provide the high-quality bioassay support for biologics production process development, manufacturing, while ensuring compliance with relevant guidelines/regulations, company SOPs, and safety regulations. 80Communicate, collaborate, and cooperate with QC functional teams and other departments to support routine project management 80Prepare, review technical documents including bioassay development reports, method protocols, qualification, transfer and validation protocols and reports, etc. 80Draft and review IND and BLA filing documents 任职要求: Qualifications 80Ph.D. with 0-2 years of experience, or Masters with 3-5 years of experience in Immunology, Analytical Chemistry, Biochemistry, Cell Biology, Molecular Biology, or other related fields. 80Technical expertise in bioassay method development and transfer, validation, and troubleshooting Biologics product-testing methods, including cell-based bioassay, ELISA to support product characterization, lot release and stability testing according to USP, EP, and ChP requirements. 80Previous experience with regulatory inspections is a plus 80Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals 80Excellent interpersonal, verbal, and written communication skills 80Able to think critically and demonstrate troubleshooting and problem-solving skills 80Self-starter and self-motivated; organized with good attention to detail 80Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
