Formation Bio

Director

• Provide technical leadership for development and manufacturing of phase appropriate formulations for Formation Bio programs.
• Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory, clinical pharmacology and project management to support short and long term program objectives.
• Oversee and manage drug product vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards.
• Author and review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations.
• Author, and contribute to regulatory submissions, including INDs, BLAs, and other regulatory dossiers.
• Support the Business Development Team with assessment of potential new assets from a technical and financial risk standpoint.

Director, Formulation Development – Small Molecule