Job Responsibilities:
Develop and implement the company's overall CMC strategy from preclinical through late-stage development, supporting R&D, clinical, and commercialization objectives;
Lead collaboration and liaison with external CDMOs, including contract review and project advancement; conduct regular audits to ensure compliance, and provide timely feedback on project progress and issues;
Lead process development and optimization, pilot-scale scale-up, technology transfer and validation, formulation development, and clinical sample manufacturing for recombinant protein drugs; organize the preparation and review of related technical documentation to ensure project timelines are met;
Coordinate internal and external resources to support drug registration applications and communications with regulatory authorities (e.g., NMPA), ensuring projects comply with regulations and guidelines in China, the United States, Europe, and other regions.
Qualifications:
Master's degree or above in Biology, Pharmaceutical Sciences, or a related field, with 10+ years of relevant experience;
Experience in leading and managing CDMO projects and teams; familiar with the development of biologics such as antibodies and fusion proteins; experience in clinical-stage development is preferred;
Familiarity with new drug R&D processes, ICH guidelines, registration regulations, GMP requirements, and CTD document preparation;
Excellent bilingual communication skills in Chinese and English, along with strong leadership, problem-solving, and teamwork abilities.