锦鲤求职岗位描述
Key Responsibilities
Develop, validate, and troubleshoot physicochemical analytical methods for the therapeutic proteins, including antibodies, fusion proteins, and related biomolecules.
Collaborate with cross-functional teams (R&D, QC, QA) to execute method transfers, investigations, and drive process improvements.
Ensure analytical activities comply with applicable regulatory guidelines, including ICH, FDA, and EMA requirements, as well as internal SOPs. Maintain current knowledge of advances in analytical technologies and industry best practices.
Serve as the primary analytical point of contact for clients, leading technical discussions and providing regular project updates.
Develop and manage analytical project plans, covering timelines, resource allocation, and deliverables, ensuring alignment with client contracts and broader CMC objectives.
Proactively identify technical risks associated with analytical activities and design and implement appropriate mitigation strategies.
Qualifications and Experience
Education and experience: Master’s degree in Analytical Chemistry, Biochemistry, Biotechnology, or a related field, with 2-5 years of relevant experience in protein analytical method development or analytical project management.
Demonstrated experience with advanced analytical technologies (e.g., HPLC, electrophoresis, etc.) and working knowledge of applicable ICH/FDA/EMA guidelines.
Strong problem-solving skills, resilience under pressure, and a collaborative mindset, with the self-motivation and organizational ability needed to drive complex projects.
Exceptional communication skills in both English and Chinese, with the ability to explain technical concepts clearly to diverse stakeholders.
Proven technical writing skills demonstrated through analytical reports, method development or validation documentation, regulatory submissions, or peer-reviewed publications.