Hengrui Pharma
Head of Analytical Sciences, Biologics Development— 恒瑞-全球精英计划
Hengrui Pharma, New York, New York, United States
We are seeking a highly experienced and strategic scientific leader to serve as the
Head of Analytical Science, Biologics
. This individual will oversee all aspects of analytical method development, qualification/validation, transfer, and quality control testing for biologics—including monoclonal antibodies, therapeutic proteins, antibody drug conjugates, and other complex modalities. The successful candidate will play a critical role in supporting development and clinical manufacturing activities, ensuring data integrity, regulatory compliance, and scientific excellence. Location: Shanghai Key Responsibilities Lead the Analytical Science function for Biologics, covering method development, method transfer, validation, and QC testing. Oversee the design, execution, and interpretation of robust analytical methods (e.g., HPLC, CE, bioassays, etc.) to support drug substance and drug product development and release. Direct stability and comparability studies, raw material testing, in-process controls, and final product testing. Responsible for identifying and evaluating Critical Quality Attributes (CQAs) and developing relevant control strategies; ensure analytical strategies align with Quality Target Product Profile (QTPP) and regulatory requirements (NMPA, FDA, EMA, ICH, etc.) throughout all phases of development and the commercial lifecycle. Build and lead a high-performing team of scientists and analysts; provide mentorship, training, and career development support. Collaborate cross-functionally with Process Development, Drug Product Development, Manufacturing, Quality Assurance (QA), Regulatory Affairs, and Project Management teams. Participate in regulatory submissions and inspections; author or review CMC sections of Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), and other regulatory filings. Champion innovation in analytical technologies and drive continuous improvement across laboratories and systems. Establish and manage departmental budgets, resource planning, and operational timelines. Qualifications PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline. 10+ years of experience in analytical development and quality control for biologics within the biopharmaceutical industry. Proven leadership and management experience in a Good Manufacturing Practice (GMP)-regulated environment. Deep technical expertise in analytical techniques used for biologics characterization and release. Strong understanding of regulatory expectations for biologics at all stages of development. Experience authoring regulatory submissions and interacting with health authorities (e.g., NMPA, FDA, EMA). Excellent problem-solving, communication, and organizational skills. Strategic thinker with a hands-on, collaborative approach to team leadership. Fluent in both Mandarin and English.
Head of Analytical Science, Biologics
. This individual will oversee all aspects of analytical method development, qualification/validation, transfer, and quality control testing for biologics—including monoclonal antibodies, therapeutic proteins, antibody drug conjugates, and other complex modalities. The successful candidate will play a critical role in supporting development and clinical manufacturing activities, ensuring data integrity, regulatory compliance, and scientific excellence. Location: Shanghai Key Responsibilities Lead the Analytical Science function for Biologics, covering method development, method transfer, validation, and QC testing. Oversee the design, execution, and interpretation of robust analytical methods (e.g., HPLC, CE, bioassays, etc.) to support drug substance and drug product development and release. Direct stability and comparability studies, raw material testing, in-process controls, and final product testing. Responsible for identifying and evaluating Critical Quality Attributes (CQAs) and developing relevant control strategies; ensure analytical strategies align with Quality Target Product Profile (QTPP) and regulatory requirements (NMPA, FDA, EMA, ICH, etc.) throughout all phases of development and the commercial lifecycle. Build and lead a high-performing team of scientists and analysts; provide mentorship, training, and career development support. Collaborate cross-functionally with Process Development, Drug Product Development, Manufacturing, Quality Assurance (QA), Regulatory Affairs, and Project Management teams. Participate in regulatory submissions and inspections; author or review CMC sections of Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), and other regulatory filings. Champion innovation in analytical technologies and drive continuous improvement across laboratories and systems. Establish and manage departmental budgets, resource planning, and operational timelines. Qualifications PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline. 10+ years of experience in analytical development and quality control for biologics within the biopharmaceutical industry. Proven leadership and management experience in a Good Manufacturing Practice (GMP)-regulated environment. Deep technical expertise in analytical techniques used for biologics characterization and release. Strong understanding of regulatory expectations for biologics at all stages of development. Experience authoring regulatory submissions and interacting with health authorities (e.g., NMPA, FDA, EMA). Excellent problem-solving, communication, and organizational skills. Strategic thinker with a hands-on, collaborative approach to team leadership. Fluent in both Mandarin and English.