• Senior Manager, CTA Regulatory Strategy…

    Otsuka America Pharmaceutical Inc. (Springfield, IL)
    …and within established budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to ... The Sr. Manager, CTA Regulatory Strategy is responsible for providing critical support...is responsible for providing critical support in developing global regulatory strategy, planning, and execution of global investigational submissions… more
    Otsuka America Pharmaceutical Inc. (04/17/25)
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  • Scientist II

    Actalent (North Chicago, IL)
    …compositions, cost-effective manufacturing processes, and by preparing and defending CMC (Chemistry, Manufacturing, and Control) regulatory content. The ... successful candidate will support both developability and formulation development efforts, working closely with a global team and scientists from multiple functional areas including Discovery, Analytical, and Process R&D. Responsibilities + Support the… more
    Actalent (05/03/25)
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  • Principal Research Scientist I, Biologics…

    AbbVie (North Chicago, IL)
    …(Biologics ARD) is a global analytical sciences organization responsible for CMC analytical activities related to the development of AbbVie's therapeutic biologic ... The candidate will serve as analytical lead on internal CMC teams and will work with external parties on...data packages that drive product and process understanding, and regulatory submission content. Major Responsibilities + As analytical lead,… more
    AbbVie (03/13/25)
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  • Associate Project Manager, Combination Product…

    AbbVie (North Chicago, IL)
    …to enable the early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director, and Delivery System Senior Leadership. ... and labeling. You will manage product development timelines and scopes to support CMC gate reviews and clinical phase plans. Collaboration with clinical teams is… more
    AbbVie (04/19/25)
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  • Principal Research Scientist I, Biologics…

    AbbVie (North Chicago, IL)
    …R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. ... rewarding career opportunities for these candidates. The ideal candidate will have CMC expertise in analytical development for biologics. The candidate will be… more
    AbbVie (05/03/25)
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  • Associate Director, Technical PDS&T

    AbbVie (North Chicago, IL)
    …expertise for marketed products and can represent the company in discussions with regulatory agencies. Due to nature of the projects and support of marketed ... significant to AbbVie's pharmaceutical Operations ($1B) to minimize back orders and regulatory risks. + Technical function is responsible for providing support for… more
    AbbVie (05/03/25)
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  • Director, Technical Operations, Eyecare

    AbbVie (North Chicago, IL)
    …and business leadership for the department. Responsibilities: + Provide mature, credible CMC leadership for Eye Care (OTC and Rx) at AbbVie + Provide ... staff of professionals to ensure that all aspects of CMC life cycle management are completed on time, within...completed on time, within budget and meet highest scientific, regulatory , quality, marketing and commercial standards + Evaluate and… more
    AbbVie (05/03/25)
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  • Senior Scientist II / Principal Research Scientist…

    AbbVie (North Chicago, IL)
    …This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery ... in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team. + May supervise and/or mentor junior level scientists and engineers.… more
    AbbVie (04/12/25)
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  • Director, Product Quality

    AbbVie (North Chicago, IL)
    … CMC Leadership Team, Product Transfers, Specification Approval Team, Regulatory Starting Material Core Team, Global Strategic Sourcing, Due Diligence, and ... introduction, product monitoring, or post-market quality systems. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), produced by… more
    AbbVie (05/03/25)
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  • Principal Research Scientist I, Analytical R&D…

    AbbVie (North Chicago, IL)
    …R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. ... knowledge sharing. + Leverage prior experience to author and review key regulatory documents, laboratory data, technical memos and reports. + The position involves… more
    AbbVie (02/13/25)
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