Sr Director, Analytical Operations

Responsibilities:

• Lead analytical development for protein-based biologics modalities, including structural characterization.
• Develop and implement pivotal and post-approval manufacturing comparability strategies (risk assessment, study design, criteria, data interpretation, regulatory justification).
• Define product-specific CQAs and analytical testing strategies for glycosylation variants and excipient-related attributes; incorporate patient-centric considerations and clinical relevance.
• Establish and maintain a state-of-the-art analytical laboratory.
• Author, review, and approve CMC sections for regulatory filings; support interactions with health agencies.
• Collaborate across PDM and partner functions (Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development, Technical Development) to enable commercialization of late-stage biologics.
• Exhibit comprehensive knowledge of cGMP.
• Drive late-stage analytical development strategies; adopt novel analytical technologies.
• Provide leadership for ~20 scientists: guidance, prioritization, career development; recruit/hire/mentor talent.

Qualifications:

• Ph.D. (12+ years) or M.S. (15+ years) in Analytical Chemistry or related field; biologics analytical development with people leader accountabilities.
• Extensive experience in analytical method development and control strategies for biologics.
• Expertise in mass spectrometry, biophysical techniques, and separation methods.
• Subject matter expert in biologics control strategies; high-throughput assays (including automation).
• Knowledge of FDA and ICH guidance for registration, quality, and compliance; regulatory documentation experience (IND/BLA/PAS).
• Working knowledge of computer validation, data governance, data science, knowledge management, and data protection.