Association of Fundraising Professionals (AFP) Silicon Valley Chapter · 4 days ago
Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics)
South San Francisco, CA
Full-time
Onsite
Mid, Senior Level
3+ years expAbbVie is dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Manager/Senior Manager, CMC Dossier Strategy and Leadership role focuses on global regulatory dossier preparation for AbbVie’s Biologics portfolio, ensuring compliance with global regulatory requirements and collaborating with CMC teams on control strategies.
Non-profit Organization Management
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
Qualification
Required
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 process development that leads to biologics drug substance and/or drug product commercial manufacturing processes, preferably including through contributions to INDs or marketing applications
Experience with CMC control strategy for biologics which aligns with ICH quality guidance
Experience authoring phase-appropriate Module 3 for IND/IMPD and BLA/MAA
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
Association of Fundraising Professionals (AFP) Silicon Valley Chapter
The Association of Fundraising Professionals Silicon Valley Chapter consists of over 300 members working to advance philanthropy through education, advocacy, research, and certification programs.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase