AbbVie · 23 hours ago
Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics)
Worcester, MA
Full-time
Onsite
Mid, Senior Level
3+ years expAbbVie is a company focused on discovering and delivering innovative medicines and solutions for serious health issues. The role involves participating in global regulatory dossier preparation for AbbVie’s Biologics portfolio, authoring submission documents, and collaborating with CMC teams to develop control strategies.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-02-04
2026-02-04
San Diego Union-Tribune
2026-02-04
Company data provided by crunchbase