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    Director, CMC Product Development - North Chicago, United States - AbbVie

    AbbVie
    AbbVie North Chicago, United States

    1 week ago

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    Description

    About the Job: Senior Manager CMC Development

    Company: AbbVie

    AbbVie is dedicated to discovering and delivering cutting-edge medicines and solutions that tackle significant health issues of today and tomorrow. The company aims to make a meaningful difference in people's lives across various key therapeutic areas, including immunology, oncology, neuroscience, and eye care. AbbVie also offers a range of products and services in its Allergan Aesthetics portfolio.

    Job Description:

    • Manages multiple projects and contributes to project prioritization
    • Represents AbbVie on high-profile partnerships and collaborations
    • Leads a global CMC team and ensures alignment with clinical and regulatory strategies
    • Actively participates in meetings with Regulatory Authorities and Pre-Approval Inspections
    • Reviews contracts with external partners and consultants
    • Oversees CMC development teams for assigned projects
    • Promotes scientific and entrepreneurial thinking within the team
    • Ensures compliance with regulatory requirements and industry practices

    Key Responsibilities:

    • Represents all CMC areas on the project team, ensuring information flow among different functions
    • Evaluates and integrates various inputs to align CMC strategies with business objectives
    • Manages multiple projects, negotiates resources, and influences timelines
    • Reviews contracts, develops budgets, and ensures project success
    • Leads CMC development teams through project milestones efficiently
    • Participates in high-profile partnerships and collaborations
    • Encourages creativity, manages quality, and ensures compliance with regulations
    • Keeps CMC Management informed of plans and risks through regular communications

    Qualifications:

    • Bachelor's/Master's/PhD degree with relevant CMC experience
    • Experience in managing global teams and CMC activities
    • Multiple product development experiences preferred
    • Strong scientific writing and verbal communication skills
    • Good knowledge of regulatory requirements and drug development processes
    • Interdisciplinary CMC experience and negotiating skills
    • Focus on leadership and entrepreneurial thinking
    • Promotion of high morale within the CMC team

    Additional Information:

    • Comprehensive benefits package offered including paid time off, insurance, and 401(k)
    • Eligible for short-term and long-term incentive programs
    • Company is committed to diversity, innovation, and serving the community
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