Director, Biologics US Operations

Biologics Operations Leadership:

• Lead late-phase process development, validation, and commercialization strategies.
• Manage and mentor a team of bioprocess and bioconjugation scientists and engineers.
• Oversee relationships with CDMOs, consultants, and other external partners.

Compliance and Regulatory Affairs:

• Ensure biologics deliverables comply with GMP requirements across multiple regions.
• Contribute to regulatory filings, including IND/IMPD, BLA, MAA submissions.
• Provide strategic input on late-stage CMC topics such as comparability and risk-based justifications.

Operational Excellence:

• Engage in cross-functional program teams, providing timeline input, options analysis, and supporting risk management and issue resolution.
• Optimize internal processes, generate technical presentations, and create documentation.