Manager​/Senior Manager, CMC Dossier Strategy and Leadership

Purpose

This position participates in global regulatory dossier preparation for Abb Vie’s 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.

• 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.

• 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.
• Appropriate level of understanding of ICH guidance for CMC control strategies.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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.

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