• Daiichi Sankyo, Inc. (Bernards, NJ)
    quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
    HireLifeScience (09/24/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
    HireLifeScience (09/24/24)
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  • Merck & Co. (Rahway, NJ)
    …have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
    HireLifeScience (09/08/24)
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  • Associate Director , CMC Lead

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take main responsibility for … more
    Daiichi Sankyo Inc. (09/30/24)
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  • Principal Scientist / Director , Global…

    Merck (Rahway, NJ)
    …GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is ... responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in… more
    Merck (09/28/24)
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  • Sr . Manager / Associate Director

    Bristol Myers Squibb (Summit, NJ)
    …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr . Manager / Associate Director , Global Sterility Assurance CTTO** ... at BMS with our Cell Therapy team. T he ** Sr Manager/Associate Director - Sterility Assurance, Cell...Cell Therapy . + Experience with regulatory inspections and CMC + Experience with Quality Management System.… more
    Bristol Myers Squibb (09/21/24)
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  • Senior Scientist/Associate Director

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
    Daiichi Sankyo Inc. (07/12/24)
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  • Senior Director Clinical Development…

    Teva Pharmaceuticals (Parsippany, NJ)
    Senior Director Clinical Development - Respiratory Date: Sep 29, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job ... be based in Parsippany, NJ or West Chester, PA Senior Director , Clinical Development is responsible for...Brochures, clinical study reports, summaries for regulatory submissions). The Sr . Director , Clinical Development will provide input… more
    Teva Pharmaceuticals (08/03/24)
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  • Senior Director , Regulatory Affairs…

    Mitsubishi Chemical Group (Jersey City, NJ)
    …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called upon ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also...claims. + Acts as liaison between Regulatory Affairs & CMC and other functional areas, including external contractors (eg,… more
    Mitsubishi Chemical Group (09/25/24)
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  • Senior Director , Manufacturing…

    Bristol Myers Squibb (Summit, NJ)
    …better place than here at BMS with our Cell Therapy team. The ** Senior Director , Cell Therapy Manufacturing Technology** leads a cross-functional team ... in Summit, NJ to ensure rapid, flawless, compliant, and cost-effective delivery of quality products. This is a critical role to ensure timely qualification of the… more
    Bristol Myers Squibb (10/04/24)
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  • Senior Scientist, Regulatory Chemistry,…

    Organon & Co. (Jersey City, NJ)
    Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls ... ( CMC ) strategies for assigned biological products in accordance with...with global regulations, guidance's and defined regulatory strategies. The Senior Scientist is responsible for the preparation and review… more
    Organon & Co. (10/03/24)
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  • Director , Biopharmaceutics

    Merck (Rahway, NJ)
    …have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non-clinical, Clinical, and ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
    Merck (09/08/24)
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  • Product Quality Lead - Early Development

    Bristol Myers Squibb (Summit, NJ)
    …careers.bms.com/working-with-us . **Position Summary:** Bristol-Myers Squibb is seeking a Product Quality Leader (PQL), Associate Director of Global Product ... individual will provide technical expertise and leadership to Product CMC / Quality Teams to develop, implement, and manage...rational manner, and demonstrated ability to work as a senior management team member and to engage and influence… more
    Bristol Myers Squibb (09/28/24)
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