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.

Application instructions:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.