Allergan Aesthetics, an AbbVie Company · 20 hours ago
Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics)
Worcester, MA, USA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$106K/yr - $202K/yr
3+ years expAbbVie is a company focused on delivering innovative medicines and solutions for serious health issues. The role involves participating in global regulatory dossier preparation for AbbVie’s Biologics portfolio, gathering information from partners, and authoring regulatory submission documents of high quality.
BeautyManufacturingPharmaceuticalWellness
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
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
H1B Sponsorship
Allergan Aesthetics, an AbbVie Company 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
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
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