• Merck & Co. (North Wales, PA)
    …increased integration of CMC and Clinical strategies.- Position Description/Summary: The CIPM Senior Specialist, Project Manager , is a core member of ... products that improve human health and business.Under GPAM, the CMC Integrated Project Management (CIPM) organization was...vaccine development efforts to progress the R&D pipeline. The Senior Specialist is expected to provide project more
    HireLifeScience (03/19/24)
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  • Novo Nordisk Inc. (Boulder, CO)
    …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... CMC , Regulatory, Quality, teams Strong organizational, planning, and project management skills, including ability to multitask and organize/track information… more
    HireLifeScience (03/23/24)
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  • Lundbeck (Bothell, WA)
    …Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has ... vast unmet medical needs associated with brain disease!SUMMARY:The Sr Manager , Lab IT is responsible for leading the lab-based...to support lab activities happening both at the Lundbeck CMC Biologics Center of Excellence in Bothell, WA, and… more
    HireLifeScience (01/20/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Manager /Sr. Manager , External Manufacture as part of the Technical Development ... organization. He/she will be the business owner of the project : overseeing the project , driving the deliverables,...driving the deliverables, managing the risks, and updating the senior leadership and stakeholders on the status and plans.… more
    HireLifeScience (02/21/24)
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  • Astellas (Westborough, MA)
    …Systems Engineer Research Associate II, Analytical Development Senior Project Manager , Technical Operations Senior CMC Regulatory Affairs Manager ... , Quality Assurance Manager , Quality Assurance Training Manager , Quality Systems Senior Manager ,... CMC Regulatory Affairs, Gene Therapy Associate Director CMC Regulatory Affairs, Gene Therapy Developing innovative therapies is… more
    HireLifeScience (01/14/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
    HireLifeScience (03/20/24)
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  • Regulatory Affairs CMC Senior

    Randstad US (Cambridge, MA)
    regulatory affairs cmc senior manager . + cambridge , massachusetts (remote) + posted march 1, 2024 **job details** summary + $75 - $86.54 per hour + contract ... to 5 education: Bachelors responsibilities: This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory… more
    Randstad US (03/13/24)
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  • Senior Manager , Regulatory Affairs,…

    BeiGene (Emeryville, CA)
    …and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality ... throughout product life cycle. Escalate the critical issues to senior management timely. . Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . . Provide CMC regulatory review for… more
    BeiGene (03/19/24)
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  • Senior Specialist, Project

    Merck (Rahway, NJ)
    …increased integration of CMC and Clinical strategies. **Position Description/Summary:** The CIPM Senior Specialist, Project Manager , is a core member of ... that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was...vaccine development efforts to progress the R&D pipeline. The Senior Specialist is expected to provide project more
    Merck (03/19/24)
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  • Senior Manager , RA CMC

    AbbVie (North Chicago, IL)
    …Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across… more
    AbbVie (03/19/24)
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  • Sr Manager , Regulatory CMC Strategy

    Pfizer (Pearl River, NY)
    …personnel to expedite approval of pending registrations and respond to queries. As a Senior Manager , your advanced knowledge of the principles and concepts in ... etc. + Serve as a Chemistry Manufacturing and Control ( CMC ) strategist and project leader for projects,...Chemistry Manufacturing and Control ( CMC ) strategist and project leader for projects, providing regulatory assessments and developing… more
    Pfizer (03/21/24)
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  • Senior Manager , Global Regulatory…

    AbbVie (Madison, NJ)
    …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., ... with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in the development… more
    AbbVie (03/26/24)
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  • Senior Specialist, Project

    Merck (Rahway, NJ)
    Project Management Office (PMO), and Administrative Professionals. **Position Description/Summary** The Senior Specialist, Project Manager is a core ... simple projects independently or moderate-complexity assignments in conjunction with a partner project manager . Projects could span any therapeutic areas in… more
    Merck (03/22/24)
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  • Senior Manager , Product Strategy

    Bristol Myers Squibb (New Brunswick, NJ)
    …communicating project plans and recommendations to matrix teams and senior leaders. + Ability to strategically frame complex opportunities into manageable ... Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve… more
    Bristol Myers Squibb (03/23/24)
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  • Senior Manager , Regulatory Affairs…

    Lauridsen Group Inc. (Ankeny, IA)
    The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and… more
    Lauridsen Group Inc. (02/08/24)
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  • Project Manager I

    AECOM (Portland, OR)
    …equitable future. Join us and let's get started. **Job Description** **AECOM** is seeking a ** Project Manager I** to be based in **Portland, Oregon** . The job ... responsibilities of the ** Project Manager ** include:...part of a field team - reports to more senior field PM, assists with duties supporting the Owner's … more
    AECOM (03/16/24)
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  • Senior Manager Regional Regulatory…

    CSL Behring (King Of Prussia, PA)
    …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our ... with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team members to enhance these relationships. + Contribute to regulatory… more
    CSL Behring (02/01/24)
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  • Senior Manager , Clinical Supply…

    BeiGene (San Mateo, CA)
    **General Description:** The Sr Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and ... to build the organization for the future. The Sr Manager of Clinical Supply Chain leads staff and provides...level to internal stakeholders (eg Clinical Operations, Regulatory, Quality, CMC ). + Work with Clinical Operations to understand clinical… more
    BeiGene (03/12/24)
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  • Senior Manager , Regulatory Affairs…

    Danaher Corporation (Washington, DC)
    …requirements are satisfied. + Provide regulatory guidance (ie, CGMP and CMC compliance requirements and trends) to internal stakeholders (eg, Commercial, R&D, ... degree, or equivalent, is required. + Demonstrated, effective Customer Service and Project Management skills are a must. + Strong writing skills (eg, proficiency… more
    Danaher Corporation (02/17/24)
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  • Senior Manager , Quality Assurance…

    Editas Medicine (Cambridge, MA)
    …of digital manufacturing strategies. + Provide QA Validation support and expertise to CMC and Tech Transfer teams. + Represent the Quality Assurance Validation group ... in project teams, audits, and inspections. + Contribute to the development of solutions to problems of varying complexity which require a high degree of ingenuity,… more
    Editas Medicine (03/13/24)
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