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

Company: AbbVie
Location: South San Francisco
Posted on: November 30, 2025

Job Description:

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Location : This position can be located at one of several locations: South San Francisco, CA; Waltham, MA; Worcester, MA; Lake County, IL. Job Description Purpose: This position participates in global regulatory dossier preparation for AbbVies Biologics portfolio activities by gathering information from internal and external partners and authoring elements of global dossiers. The role prepares sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Partners with CMC teams during the development of CMC control strategies. Implement well-defined, efficient processes for preparation of these CMC documents. 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. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: On-site: This positions will operate in a hybrid working model, where 3 days on-site per week will be required (Tuesday, Wednesday, Thursday). Location: This position can be located at one of several locations: South San Francisco, CA; Waltham, MA; Worcester, MA; Lake County, IL. The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Keywords: AbbVie, South San Francisco , Manager / Senior Manager, CMC Dossier Strategy and Leadership (Biologics), Science, Research & Development , South San Francisco, California