Senior Director, Analytical Development

Responsibilities

• Lead and organize the analytical development team to coordinate project research progress and ensure successful implementation of project plans.
• Direct the analytical team in method development, stability studies, method confirmation, and method transfer to support process development and product release testing.
• Oversee daily analytical testing for upstream and downstream R&D teams.
• Manage internal and cross-departmental coordination, reviewing experimental results and resolving technical issues promptly.
• Communicate and collaborate with CRO/CDMO partners to drive project progress.
• Supervise laboratory operations, instrument management, and ensure the integrity, authenticity, and compliance of all research data.
• Manage departmental talent through training, development, and performance evaluation systems.
• Author or review regulatory submission materials and original records in accordance with drug registration requirements, supporting IND and BLA filings and site inspections.

Requirements

• Master's degree with 10+ years of experience or a PhD with 8+ years of experience in drug analysis, biotechnology, biochemistry, or analytical chemistry.
• 5+ years of experience managing quality analysis teams within a large biopharmaceutical company.
• Proven expertise in characterization platforms and mass spectrometry, including protein drug characterization (primary structure, PTMs, disulfide bonds, higher-order structure, biological activity, and heterogeneity).
• Technical proficiency in analytical techniques such as HPLC, LC-MS, CE, iCIEF, DSC, CD, and BLI.
• Deep understanding of analytical method development, optimization, transfer, and validation processes.
• Extensive knowledge of biochemical quality analysis methods, including antibody/recombinant protein content, binding activity, HCP, Protein A, and residual DNA.
• Strong familiarity with NMPA, FDA, and ICH regulatory guidelines and requirements.
• Hands-on experience with IND and BLA filings.
• Comprehensive knowledge of cGMP, ICH, and pharmacopeia standards (ChP, USP).
• Excellent communication and coordination skills, with proficiency in written and spoken English.

About the Company

BioNTech is a leading biotechnology company pioneering novel therapies for cancer and other serious diseases.