Hengrui Pharma
Head of Analytical Sciences, Biologics Development— 恒瑞-全球精英计划
Hengrui Pharma, Princeton, New Jersey, us, 08543
Position
HR Management Trainee | Talent Acquisition at Hengrui Pharmaceuticals Location: Shanghai 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. Identify and evaluate Critical Quality Attributes (CQAs) and develop 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.
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HR Management Trainee | Talent Acquisition at Hengrui Pharmaceuticals Location: Shanghai 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. Identify and evaluate Critical Quality Attributes (CQAs) and develop 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.
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