Job Description

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.

Job Tags

Similar Jobs