• Merck & Co. (Rahway, NJ)
    …strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of ... to patients in markets as needed.-Primary Responsibilities:Lead a small team of CMC regulatory scientists responsible for new modality or traditional solid-oral… more
    HireLifeScience (10/01/25)
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  • Merck & Co. (Rahway, NJ)
    …strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory ... oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful… more
    HireLifeScience (10/01/25)
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  • Merck & Co. (Rahway, NJ)
    …of business functions including Technology, Manufacturing Operations, Finance, Regulatory , Quality, Compliance, Supply Chain and Commercial. Understanding of ... product development lifecycle and integration of CMC and clinical strategy and ability to engage to...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
    HireLifeScience (10/02/25)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging...new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and… more
    HireLifeScience (09/23/25)
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  • Director , Regulatory Site

    Takeda Pharmaceuticals (Boston, MA)
    …of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant ... based on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and… more
    Takeda Pharmaceuticals (08/28/25)
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  • Executive Director , Regulatory

    Merck (Rahway, NJ)
    …your career. The Executive Director , Chemistry, Manufacturing & Controls ( CMC ), Pre-approval Pharm will bring scientific and regulatory expertise, innovative ... to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory...conjugates (ADCs), and traditional solid-oral small molecules. The Executive Director will help drive our company's growth into new… more
    Merck (10/01/25)
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  • Senior Advisor/ Director Global…

    Lilly (Indianapolis, IN)
    …all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in...with CMC team members. + Engage in site -specific regulatory activities to ensure maintaining registered… more
    Lilly (09/03/25)
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  • Director , Scientific Expert CMC

    Boehringer Ingelheim (Athens, GA)
    …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
    Boehringer Ingelheim (09/12/25)
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  • Associate Director - CMC Development…

    Lilly (Philadelphia, PA)
    …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
    Lilly (08/12/25)
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  • Associate Director / Sr. Associate…

    Boehringer Ingelheim (Ridgefield, CT)
    …Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located ... for leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director more
    Boehringer Ingelheim (09/12/25)
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  • Associate Director / Sr. Associate…

    Boehringer Ingelheim (Ridgefield, CT)
    …Ingelheim is seeking an experienced Associate Director or Senior Associate Director , Analytical to join the External Alternative CMC Development (EACD) team ... relevant external scientific bodies / consortia **Compensation Data** This position, Associate Director , External Alternative CMC Development (EACD) , offers a… more
    Boehringer Ingelheim (10/01/25)
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  • CMC Lead, Small Molecules

    Takeda Pharmaceuticals (Boston, MA)
    …to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules (Associate Director ), you will be responsible for leading ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
    Takeda Pharmaceuticals (09/13/25)
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  • Associate Director Global Regulatory

    CSL Behring (King Of Prussia, PA)
    …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges, ... make a meaningful difference worldwide. Could you be our next Associate Director Global Regulatory Lead, EHT (Enabling Healthcare Technologies encompasses… more
    CSL Behring (09/26/25)
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  • Senior Director , Head of Potency…

    Bristol Myers Squibb (Devens, MA)
    …alongside some of the brightest minds in Biopharma. **Position Summary** The Senior Director , Head of Potency and Impurity Assay Development (PIAD) reports to the ... of subject matter experts to orchestrate and execute, within the network, CMC potency and impurity strategy and structure-function understanding of product quality… more
    Bristol Myers Squibb (10/01/25)
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  • Director , Vector Product Champion

    Bristol Myers Squibb (Devens, MA)
    …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
    Bristol Myers Squibb (09/26/25)
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  • Senior Director , Site Quality Head,…

    Teva Pharmaceuticals (Parsippany, NJ)
    Senior Director , Site Quality Head, Goa Date:...technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep ... to ensure a mature culture of quality, compliance with regulatory requirements and quality of products. This oversight includes...Practices **Location** This role is based on the Teva site in Goa, India. **How you'll spend your day**… more
    Teva Pharmaceuticals (09/06/25)
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  • Associate Director - Supply Chain

    Lilly (Philadelphia, PA)
    …to make life better for people around the world. **Position Overview:** The Associate Director , Supply Chain will lead and grow a supply chain team responsible for ... is a hybrid position requiring a minimum of three days per week on- site at the Philadelphia office. **Responsibilities:** + Ensure uninterrupted supply of critical… more
    Lilly (10/02/25)
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  • Director , Viral Vector Process Design

    Gilead Sciences, Inc. (Santa Monica, CA)
    …development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly ... collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners. In addition,… more
    Gilead Sciences, Inc. (09/07/25)
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  • Director , Cell Banking Leader

    Merck (Rahway, NJ)
    …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing ... oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful… more
    Merck (10/01/25)
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  • Director , Engineering - Drug Product…

    Merck (West Point, PA)
    …(DoE) and statistical data analysis. + Experience in authoring and reviewing CMC regulatory documentation. + Financial acumen with experience in resource ... **Job Description** **Job Description: Director , Center of Excellence for Sterile Drug Product...+ Experience with implementing platforms and standard work in CMC commercialization, technical operations or manufacturing + Experience with… more
    Merck (09/24/25)
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