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

Role Summary

Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics) participates in global regulatory dossier preparation for AbbVie’s Biologics portfolio, authoring elements of global dossiers and partnering with CMC teams to develop control strategies. Responsible for delivering high-quality regulatory submission content and implementing efficient processes for CMC documentation.

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 consult 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 to identify opportunities, gaps and synergies consistent with improving efficiency within the role.

Qualifications

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

Education

• Not specified

Additional Requirements

• On-site: Hybrid model requiring 3 days on-site per week (Tuesday, Wednesday, Thursday).
• Location: South San Francisco, CA; Waltham, MA; Worcester, MA; Lake County, IL.