Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics)

Role Summary

Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics)

Responsibilities

• Authors sections of IND/IMPDs, BLAs/MAAs, and regional requirement documents.
• Gathers and/or authors source information from internal and external partners required to support dossier authoring activities.
• Authors data-rich sections of INDs and MAAs based on current best practices. Authors narrative-rich sections of early-phase INDs.
• Embedded in complex CMC development teams to collaborate on forging CMC control strategies and plan for the data packages that will support the strategies.
• Manage IND/IMPDs dossier submission timelines and supporting activities for early-stage programs.
• Participate in quality checks to ensure the accuracy of dossier content and consults SMEs as needed.
• Contributes to developing automation tools to enhance authoring efficiency.
• Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement projects.
• Establish and maintain strong networks within departments and external stakeholders. Utilize an established organizational network to identify opportunities, gaps and synergies consistent to improve efficiency within role.

Qualifications

• Manager: Bachelors with 8, Masters with 6, or PhD with 3 years of CMC biologics functional experience.
• Senior Manager: Bachelors with 10, Masters with 8, or PhD with 5 years of CMC biologics functional experience.
• Prior experience in a relevant laboratory conducting development work, preferably including through contributions to INDs or marketing applications.
• At least basic understanding of ICH guidance for CMC control strategies.